Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed TomographyApr 2013
The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In this prospective study the investigators validate DE-CT results of patients against hemodynamic parameters from right heart catheterisation and control the results by other clinical investigations. The investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.
Physiotherapy in Exacerbation Chronic Obstructive Pulmonary DiseaseMar 2013
Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea and the quantity of sputum purulence). This is known as exacerbation and it is the most frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program is carrying out in patients attending to the Hospital because of an exacerbation. The hypothesis of this study is that a physiotherapy program added to a medical treatment increase the ventilatory function, the physiques variables, decrease depression and anxiety and improve the quality of life. Additionally, it is going to be assessed the effect of physiotherapy in time using phone calls and visits to the patient's home.
Vincristine or cis-platin, both in combination with gemcitabine or pemetrexed for the treatment of advanced non-small cell lung cancer – VIP trialMar 2013
Primary objectives of the trial: quality of life; treatment side effects
Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer (BASALT-2)Mar 2013
The Phase Ib part of the study aims to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study is to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC.
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)Mar 2013
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia (LAMVIRE)Mar 2013
Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% InhalationsMar 2013
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)Mar 2013
This study will treat patients with advanced NSCLC with a combination of standard first line platinum-containing doublet chemotherapy and selumetinib. It will help to understand what is the best tolerated combination of doses of the three agents, and what type of side effects may occur when the three agents are given in combination. In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.
A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients with Community-Acquired Bacterial PneumoniaMar 2013
To determine noninferiority (NI) in early clinical response rate (defined as improvement at 72 [±12] hours after the first dose of study drug), in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production, (without worsening of any) of oral solithromycin compared to oral moxifloxacin in adult patients with community-acquired bacterial pneumonia (CABP) in the Intent to Treat (ITT) population.
Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients (Hp-in-CF)Mar 2013
Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. Usually severity is determined by the class of CF mutations, but even among patients with the same severity of mutations there is a variation of the severity of CF. Haptoglobin has several types (phenotypes), one of them was found to be related to infectious complications. In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications. To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial PneumoniaFeb 2013
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia (UGENT_LIMOP)Feb 2013
The objectives of the study are: (i) to evaluate the proportion of patients who attain a T>MIC (Minimum Inhibitory Concentration) of 100% and the time frame in which they do so. The investigators therefore plan to measure unbound linezolid trough concentrations before administration of the second, third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or fifth dose, when steady state conditions are reached. (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this cohort using a population pharmacokinetic model and to assess the expected probability of target attainment (PTA) by MIC against MRSA.
A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)Feb 2013
This study will evaluate safety, tolerability and effects on central diastolic blood pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and in male participants with mild-to-moderate hypertension (Panel C).
A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)Feb 2013
The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous cell NSCLC.
MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials.Feb 2013
To describe the safety profile of mepolizumab in subjects receiving long-term treatment
LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLCFeb 2013
The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment. Secondary objectives of the study are - to assess safety of the treatment modality by collecting data about acute and late toxicity - patterns of local and distant recurrence and relation between the site of local recurrence and the clinical (CTV) and planning target volume (PTV) - survival and cause of death
Monitoring of Lung Sounds of Patients With PneumoniaFeb 2013
The aim of this study is to investigate if any correlation between lung sounds of pneumonia patients and the clinical development or therapy of the pneumonia exists.
Immuno-humoral Rejection Markers in Pulmonary Transplant (RHUM-TP)Feb 2013
Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.
A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexiaFeb 2013
Assess the effect of i.v. infusion of BYM338 on muscle volume of the thigh (assessed by MRI) compared to placebo
An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)Feb 2013
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.
A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (UV1-hTERT2012L)Feb 2013
In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
Acid-suppressing Drugs Pregnancy Asthma Offspring StudyFeb 2013
The purpose of this study is - To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood. - To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.
Bone Microarchitecture in Young Cystic Fibrosis PatientsFeb 2013
The aim of this study is to evaluate bone microarchitecture of paediatric CF patients matched to sex-age-pubertal status-healthy volonteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)Feb 2013
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.
Parp Inhibitor in Advanced Non-Small Cell Lung Cancer (PIN)Feb 2013
The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC tumours that respond to chemotherapy are less able to repair this damage. This can be exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of mutation in two or more genes leads to cell death.
To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)Feb 2013
The primary objective of this study is to assess and compare the pharmacokinetics (PK) of Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day), SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day) following repeat dosing for 7 days in subjects with COPD.
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)Feb 2013
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.
Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic PatientsJan 2013
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic FibrosisJan 2013
Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.
A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung CancerJan 2013
The main objectives of this study are: - to compare the overall survival of previously treated subjects with squamous non-small cell lung cancer treated with MK3475 compared to docetaxel. - to compare overall response rate as determined by immunerelated response criteria of previously treated subjects with squamous non-small cell lung cancer treated with MK3475 compared to docetaxel. - Evaluate safety and tolerability profile of MK3475 in previously treated subjects with squamous non-small cell lung cancer
A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPDJan 2013
Compare the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25mcg once daily) with fluticasone propionate/salmeterol (500/50mcg twice-daily) over 12 weeks in subjects with COPD who have a history of infrequent COPD exacerbations
Ext. Long-term Safety Study in CF Patients: Single Arm TIPJan 2013
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients (DAILY)Jan 2013
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
Respiratory Function and Walking Capacity in Multiple SclerosisJan 2013
Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. It is possible that respiratory dysfunction influence physical fitness in earlier stages as well. Walking disability and fatigue causes significant impact on health in patients with MS, even in earlier stages. The hypothesis is that there is a relationship between respiratory function, walking capacity and fatigue and that daily deep breathing exercise during two months will improve respiratory function, walking capacity and fatigue.
Effect of Glococorticosteroids on physical performance in patients with chronic obstructive pulmonary disease and acute inflammatory response after exerciseJan 2013
The purpose of this trial is to investigate the effects of the drugs prednisone and Solu-Medrol on physical performance in patients with COPD
MACCE in Hospitalized Patients With Community-acquired PneumoniaJan 2013
Community-acquired pneumonia is the most common infection leading to hospitalization in intensive care units and the most common cause of death associated with infection disease. Epidemiological studies have shown that respiratory tract infections are associated with an increased risk for the development of acute cardiovascular and cerebrovascular events. This link is further supported by studies indicating that influenza vaccination is associated with a reduced risk of hospitalization for pneumonia as well as heart disease and cerebrovascular disease. Data connecting acute respiratory tract infections and cardiovascular events stem almost exclusively from cross-sectional or retrospective studies. Thus the real incidence and the prognostic impact of AMI, as well as the pathophysiological relationship between pneumonia and cardiovascular damage is still elusive. Inflammation plays a major role in the pathogenesis of coronary artery disease. The increased concentrations of proinflammatory cytokines together with the activation of coagulation, the down-regulation of anticoagulant mechanisms and the enhanced platelet aggregation may trigger atheroma's instability, plaque rupture and thrombus formation. Inflammation and coagulopathy are also considered universal host responses to infection in patients with severe sepsis. Thus far limited data are available on the changes in these high regulated systems, together with platelet activity in patients with CAP and their potential relationship with cardiovascular risk. This project will consist in a prospective multicenter study to investigate the incidence of major adverse cardiac and cerebrovascular events (MACCE) in hospitalized patients with CAP, its prognostic relevance and the potential relationship between enhanced cardiovascular risk and the activation of inflammation, coagulation and platelet aggregation in this setting.
NSCLC Burden of Illness Study (LuCaBIS)Jan 2013
The aim of this observational study is to identify and quantify the humanistic and economic burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data collection will be conducted through patient medical record abstraction and patient survey.
Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma (ASMATHERM)Jan 2013
To determine, from patients presenting severe asthma and an increase in bronchial smooth muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function
A 52-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD.Jan 2013
To demonstrate that QVA149 (110/50 μg o.d.) is at least noninferior to salmeterol/fluticasone (50/500 μg b.i.d.) in terms of rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment.
Intervention Study to Investigate Supplemental Oxygen in COPDJan 2013
The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test. Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.
Control and Burden of Asthma and Rhinitis (ICAR)Jan 2013
An observational cross-sectional study will include 750 individuals of all ages, divided in 4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory symptoms or diseases (n=300)
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung CancerJan 2013
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home (OCTAGEN)Jan 2013
To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS) controller treatment guided by exhaled NO measurement made at home with usual care asthma management with regard to asthma control (primary outcome), asthma-related quality of life, lung function, airway inflammation, medication use, and asthma events. To understand changes in patient behaviour triggered by daily FENO measurement at home, for example treatment adherence and voluntary allergen exposure.
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.Jan 2013
To evaluate the risk of serious asthma related events during treatment with Symbicort pMDI or budesonide pMDI alone (asthma-related deaths, intubations, hospitalizations).
Roflumilast Plus Montelukast in Adults With Severe AsthmaJan 2013
The purpose of this study is to evaluate the effect of roflumilast alone and in combination with montelukast on forced expiratory volume in 1 second (FEV1) in patients with inadequately controlled asthma.
A 12-week treatment, multi-center, randomized, double-blind, parallel group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate /glycopyrronium bromide) in COPD patients with moderate to severe airflow limitationJan 2013
To demonstrate the superiority of QVA149 27.5/12.5 μg b.i.d. compared to monotherapy components, QAB149 27.5 μg b.i.d. and NVA237 12.5 μg b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.
Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH)Jan 2013
Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.
A phase I/II study of first line Ganetespib with pemetrexed/cisplatin, in patients with malignant pleural mesotheliomaDec 2012
The principal research question for the phase I study is to find the maximum tolerated dose of Ganetespib, and use this information with the number of chemotherapy cycles administered to determine the most appropriate dose of Ganetespib for the phase II trial. For the phase II study, the principle research question is to determine whether adding Ganetespib to pemetrexed and cisplatin using the dose from the Phase I part of the study, versus pemetrexed and cisplatin chemotherapy improves progression free survival (first disease progression or death of any cause).
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator ReversibilityDec 2012
To evaluate the efficacy of brodalumab compared with placebo as measured by the change in asthma control (based on the Asthma Control Questionnaire [ACQ]) from baseline at week 24 in subjects with inadequately controlled asthma and high reversibility despite standard of care.
A Multicenter Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily with Tiotropium 18 mcg Once Daily over 24 Weeks in Subjects with Chronic Obstructive Pulmonary Disease (COPD)Dec 2012
The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 24 weeks for the treatment of subjects with COPD.
Multicentre, randomised, double-blind, parallel group, placebo-controlled study on the therapeutic efficacy and safety of beclomethasone dipropionate suspension for inhalation 800 micrograms twice daily vs placebo added to antibiotic therapy in patients with acute rhinosinusitisDec 2012
To demonstrate that BDP suspension for inhalation twice a day for 14 days added to antibiotic therapy improves clinical success rate and accelerates recovery in patients with acute rhinosinusitis.
The Effects of Atorvastatin Treatment in COPD PatientsDec 2012
This study aims to determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD.
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects with Persistent AsthmaDec 2012
This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second (FEV1). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with monteulkast over 12 weeks.
Phase II trial of oral vinorelbine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) positive mutation after a failure to treatment with EGFR Tyrosine Kinase Inhibitors (TKI) in first line.Dec 2012
To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor
Simvastatin as adjuvant therapy to correct neutrophil dysfunction in older pneumonia patients - a randomised double blind placebo controlled trialNov 2012
Pneumonia (severe lung infection) is one of the commonest causes of death and the death rate has not fallen for many years. Elderly patients are at greater risk of pneumonia and its complications such as sepsis. Usually the immune system works cooperatively to clear infection and prevent organ damage. Neutrophils are cells of the immune system that are critical in clearing bacteria. These cells are the foot soldiers of the immune system and move from the blood into infected tissues/organs to locate and kill the invading bacteria using an arsenal of toxic products. Sepsis occurs when the bodies normally helpful reaction to infection becomes harmful. As part of this process, neutrophils stop working properly, they become less able to clear bacteria and release their toxic products indiscriminately, causing organ damage. Defects in the efficiency of these cells is associated with a poor outcome from pneumonia and sepsis.
Pneumonia treated with rifampicine attenuates inflammationNov 2012
To demonstrate reduced release of inflammatory components from the bacterial cell wall by adding a short course of rifampicin to standard medical treatment of community acquired pneumonia. In this way less inflammatory biomarkers will be released and less inflammation may lead to shorter duration of hospitalization en more rapid improvement of symptoms (morbidity).
Ambulatory Oxygen Effects on Muscles in COPD (OM-COPD)Nov 2012
Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.
A phase II, multicenter, single-arm study of oral LDK378 in crizotinib naïve adult patients with ALK-activated non-small cell lung cancerOct 2012
To demonstrate the antitumor activity of LDK378, as measured by overall response rate (ORR) to LDK378 by investigator assessment
Variations in plasma concentration in patients with non-small cell lung cancer on fixed-dose erlotinibOct 2012
The hypothesis of the project is that erlotinib given as at a fixed dose of 150mg to all patients’ results in a variable plasma concentration of the drug. This would in turn lead to a variation in anticancer effect and toxicity. The project will determine the size of this person-person variability. Should a sizeable difference be found, it would indicate the need for further studies of potential differences in anticancer activity and toxicity and a re-assessment of drug dosage.Erlotinib hydrochloride is the active substance of Tarceva, which is used to treat advanced stage non small cell lung cancer and pancreatic cancer. This project deals with non small cell lung cancer (NSCLC) patients only. Erlotinib is a reversible tyrosine kinase inhibitor (TKI), that specifically targets the epidermal growth factor receptor (EGFR), which is sometimes highly expressed and occasionally mutated in various forms of cancer.
What is the clinical and cost effectiveness of oral steroids in the treatment of acute lower respiratory tract infection (LRTI)? A placebo controlled randomised trialOct 2012
Does the use of oral prednisolone reduce the duration of moderately bad or worse cough and / or the severity of all its associated symptoms on days 2 to 4 by at least 20% when compared to no steroid treatment in adults ≥18 years presenting to primary care with acute LRTI?
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. (1716-12)Oct 2012
This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.
A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocationOct 2012
To compare the effects of treatment every two weeks with 240 mg QGE031 versus omalizumab in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline
Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and ExerciseOct 2012
Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced exercise capacity. This is because their lungs are damaged and because of increased work of breathing. In some patients, exercise capacity is reduced to such a level that even simple activities of daily living, such as washing and dressing, may impose a challenge. Recent findings in healthy young people suggest that increasing the amount of nitrate in our diet in the form of beetroot juice can improve the ability to exercise. Studies involving cycling have shown that less oxygen is needed to perform the same level of exercise after taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be converted in the body to nitric oxide (NO), a substance which increases blood flow and may affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that such dietary nitrate supplementation appears to reduce the amount of oxygen needed to complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of this study to see if such effects could be seen in COPD patients. If this is indeed the case, then it may suggest that a period of dietary supplementation of a relatively cheap, widely available, and natural food product may improve the ability of patients to undergo everyday tasks and ultimately improve their quality of life. To help investigators understand the effects of dietary nitrate supplementation on the ability to exercise in COPD patients, the investigators will recruit 15 people with mild to moderate disease. They will complete a series of undemanding exercise tests on three separate occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading up to the tests, and on the other occasion they will have had a course of beetroot juice with the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow us to assess any effects that may have occurred as a result of increased nitrate intake.
The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitisOct 2012
To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years.
Pilot study to downregulate allergic responses in adults with allergic rhinoconjunctivitis by using three intralymphatic injections of grass or birch allergen one month in between during the non-seasonal period.Oct 2012
Effect on subjective symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first season.
A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients with Moderate to Severe Allergic Asthma not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)Sep 2012
The primary objective of this study is to assess the therapeutic potential and safety/tolerability of QbG10 at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard inhaled corticosteroids (ICS) with or without long-acting β2 agonist (±LABA) therapy (Global Initiative for Asthma [GINA] steps 3 and 4)
A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant RecipientsSep 2012
a) To estimate the time taken to achieve a steady level (steady state) of posaconazole in the blood in cystic fibrosis (CF) and non-CF transplant recipients. b) To examine the relationship between blood posaconazole levels and posaconazole levels in the lungs in cystic fibrosis (CF) and non-CF transplant recipients.
Prognosis and Treatment of COPD in Primary Care-use of Biomarkers (PROTECCT-M)Sep 2012
This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).
Significance of COX-2 inhibition in first line treatment of extensive disease small-cell lung cancer (ED-SCLC)Sep 2012
Investigate the efficacy of combination of celecoxib and standard chemotherapy as first line treatment for ED-SCLC
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled, Persistent AsthmaAug 2012
To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (≥fluticasone 500 µg or the equivalent daily) and long acting β2 agonists.
Efficacy of gencydo nasal spray on early nasal response after allergen exposition in patients with grass pollen allergy: a randomized, placebo controlled cross over studyAug 2012
Clinical efficacy of Gencydo nasal spray on early allergic response to grass pollen in patients with grass pollen allergy
A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB)Aug 2012
The primary objective is to demonstrate that TMC207 added to a BR is superior to this BR plus placebo in regard to the proportion of subjects with favourable treatment outcome 60 weeks after randomization (i.e., 36 weeks of treatment and 24 weeks of treatment-free follow-up). A favourable treatment outcome requires confirmed culture conversion at Week 60.
Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and of voriconazole in patients with cystic fibrosis and presenting with persistent positive sputums for AspergillusAug 2012
We wish to ascertain the effectiveness of the two possible treatments for Aspergillus infection in CF (voriconazole and itraconazole) and compare these to each other. Effectiveness will be assessed by the effect on growth of Aspergillus in the sputum, which we will also confirm with more sensitive techniques based on detecting Aspergillus DNA.
A phase II observer blind, randomised, controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccine GSK 692342 when administered to adults aged 18 to 59 years with TB diseaseAug 2012
To assess the safety and reactogenicity of GSK Biologicals’ candidate TB vaccine M72/AS01E in the study population.
A multicentre, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of AllerT, a combination of contiguous overlapping peptides derived from Bet v 1, in adult subjects allergic to birch pollenAug 2012
To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
A multicenter, randomized, double-blind, placebo controlled, 12-week treatment, parallel-group study to assess the efficacy, safety and pharmacokinetics of indacaterol acetate (75 and 150 μg o.d.) in patients with persistent asthmaAug 2012
To demonstrate superiority of indacaterol acetate 75 or 150 μg to placebo with respect to 24 h postdose trough FEV1 after 12 weeks of treatment in patient with persistent asthma.
A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureusAug 2012
• Evaluate the efficacy of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with community-acquired bacterial pneumonia (CABP) at risk for infection due to methicillin-resistant taphylococcus aureus (MRSA) • Evaluate the safety of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with CABP at risk for infection due to MRSA • Evaluate the pharmacokinetics of ceftaroline in adult subjects with CABP at risk for infection due to MRSA
Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD PatientsAug 2012
The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water inhalation on oxidant stress in the airways of stable COPD patients.
A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat PoorAug 2012
Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.
A second-line, single arm, phase II clinical study with tremelimumab, a fully humanized anti-CTLA-4 monoclonal antibody, as monotherapy in patients with unresectable malignant mesotheliomaAug 2012
To assess the rate of objective clinical complete response (CR) or partial response (PR)
A Phase III, International, Multi-Center, Randomised, Double-Blind, Placebo-Controlled, Event Driven Study to compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension receiving UT-15C in Combination with a PDE5-I or ERA compared with a PDE5-I or ERA AloneAug 2012
To assess the effect of oral UT-15C with ERA or PDE5-I therapy compared to placebo with ERA or PDE5-I therapy on time to first clinical worsening event, as defined by at least one of the events: Death (all causes),Hospitalization due to worsening PAH, Initiation of an inhaled or infused prostacyclin for the treatment of worsening PAH, Disease progression (all criteria required), Unsatisfactory long-term clinical response(all criteria required). To assess effect of UT-15C combined with oral ERA or PDE5-I therapy compared with placebo combined with oral ERA or PDE5-I therapy on the change in Baseline 6MWD measured at Week 24
Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)Aug 2012
Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular disease is a major cause of death in such patients and it may be related to excess stiffening of the walls of major arteries, such as the aorta, and it has been suggested to represent premature aging. However, there is little known of the development of these problems, which were previously considered to be due to smoking and which is now known not to be the only factor. The investigators will study a large group of patients with mild to very severe airflow obstruction based on the NICE 2010 classification of severity and a matched comparator group free of COPD. This study involves three assessments of the development of the complications of COPD over a five year period. The key measure will be the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in wall stiffness will be related to the severity of lung disease; other known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular events including heart attacks and death; and to the presence of other complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the context of changes in bodywide inflammation and metabolic function and the changes in the rate of ageing. This increased knowledge of interacting factors in the complications of COPD is likely to lead to studies of treatments to avoid their development.
An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310Aug 2012
The primary objective of this study is to provide UT-15C sustained release tablets for eligible subjects who participated in TDE-PH-310 (A phase III, International multi-center, randomised, double-blind, placebo-controlled, event-driven study to compare the time to first clinical worsening in subjects with PAH receiving UT-15C in combination with a PDE5-I or ERA compared with a PDE5-I or ERA alone).
Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.Jul 2012
To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction.
A signal seeking window trial of AZD8931 in patients with resectable non-small cell lung cancerJul 2012
The primary objective of the study is to determine whether a 40mg twice daily dose of AZD8931 administered for 10-14 days (up to 18 days if surgery recheduled) results in suppression of cancer cell growth, by looking at changes in a marker called Ki67, which represents proliferation of tumour cells, before and after treatment with AZD8931.
A Phase IIa Exploratory Study of OCZ103-OS in Combination with Platinum-Gemcitabine based Doublet First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) PatientsJul 2012
To obtain a preliminary evidence of the clinical efficacy of OCZ103-OS used in combination with platinum-gemcitabine based doublet first line therapy in adult NSCLC patients, by assessing primarily Overall Response Rate (ORR), as well as Duration of Response (DR), Progression Free Survival (PFS), Overall Survival (OS), Time to progression (TP) and Time to Distant Metastasis (TDM)
Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections (ESTUAR)Jul 2012
The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections
Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections (ESTUAR)Jul 2012
The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections
An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) Pharmacogenetics Blood Sample Protocol Amendment 01 version 1.0 dated 12-Jun-12Jul 2012
The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy
Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPDJul 2012
The purpose of this project is to investigate whether a 12-week, fulltime pulmonary rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD).
MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory AsthmaJul 2012
To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS) in systemic corticosteroid dependent subjects with severe refractory asthma with elevated eosinophils.
An open-label phase II trial of erlotinib and bevacizumab in patients with advanced non-small cell lung cancer and activating EGFR mutationsJul 2012
To determine progression free survival (PFS) of patients with advanced non-squamous NSCLC harbouring at diagnosis EGFR mutations with and without T790M mutation, treated with the combination of erlotinib and bevacizumab. Hypotheses of interest: When treated with bevacizumab and erlotinib a. Median PFS increases to 18 months for patients with EGFR T790M mutation b. Median PFS is approximately 18 months or more in patients without EGFR T790M mutation.
Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)Jul 2012
To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD
A Randomised, Double-blind, Single-centre, Controlled Trial of Low Dose Intradermal Allergen Immunotherapy in Adults with Seasonal Allergic RhinitisJul 2012
The primary objective is to determine if pre-seasonal low dose intradermal grass pollen allergen immunotherapy (either 7 or 8 two-weekly injections of 10 Biological Units (33.333 SQ-U)) reduces symptoms and requirements for anti-allergic drugs in seasonal allergic rhinitis during the 2013 grass pollen season compared to the control intervention (histamine only).
Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease (EPIC)Jun 2012
The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.
Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinomaJun 2012
To assess the antitumor activity of CAP7.1 based on the observed objective rersponse rate and rate of disease stabilization using Recist.
Biological standardization of allergen extracts of pollen of Artemisa vulgaris and Platanus acerifolia and the acarus Dermatophagoides farinae in patients sensitized to them.Jun 2012
In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.
A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects with Asthma Inadequately Controlled by CorticosteroidsJun 2012
The primary objective of study KB003-04 is to evaluate the effect of KB003 on lung function in subjects with asthma inadequately controlled by corticosteroids, as measured by absolute change in percent predicted FEV1.
A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapyJun 2012
To evaluate the clinical efficacy and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different total daily doses of Fluticasone Propionate Inhalation Powder taken using a twice daily regimen from nDPI for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines (GINA 2011).
An evaluation of adherence to LTBI treatment with 12 doses of once weekly rifapentine and isoniazid given as self-administered versus directly-observed therapy: iAdhereJun 2012
To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.
A phase IIb, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and dosing regimens of MEMP1972A in adults with allergic asthma who are inadequately controlled on inhaled corticosteroids and a second controller (COSTA)Jun 2012
The primary objectives of this study are to evaluate the efficacy and safety of MEMP1972A in adult patients with allergic asthma inadequately controlled despite high dose inhaled corticosteroids ( ICS) (≥ 400 μg/day total daily dose of fluticasone propionate [FP] or equivalent) and a second controller after 36 weeks of treatment.
A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)Jun 2012
Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive NSCLC
A randomized, double-blind, double-dummy, 4-week treatment, parallel-group study to evaluate the efficacy and safety of two doses of mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthmaJun 2012
To demonstrate the non-inferiority of MF 80 µg and 320 µg delivered via Concept1 to MF 200 µg and 800 µg delivered via Twisthaler® in terms of 24 h post-dose trough FEV1 after 4 weeks treatment.
Phase I Hybrid study: combined stereotactic radiotherapy and conventional fractionation in stage II and III non small cell lung cancer with peripheral tumors smaller than 5 cmJun 2012
To define the recommended phase II mean-lung dose (MLD) to treat peripheral stage II or III non small cell lung cancer (NSCLC) using stereotactic ablative radiotherapy (SABR) for the primary tumor and conventional fractionated radiotherapy (CFRT) for the mediastinal lymph nodes while given concurrent chemotherapy
Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell lung cancer (NSCLC)Jun 2012
To evaluate and compare objective response rates in both arms while defining toxicity profiles of both application schedules. Additionally, evaluation of biologically validated, potentially predictive biomarkers and identification of new biomarkers for therapy response, therapy resistance, and course of disease in formalin-fixed paraffin-embedded (FFPE) and fresh tumour specimens as well as circulating tumour cells (CTCs), obtained before treatment and, if applicable, during and after study treatment.
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung CancerMay 2012
The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.
A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLCMay 2012
This study tests the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line NSCLC in participants with all target lesions expressing the folate receptor [FR(++)]. Primary objective: progression free survival (PFS)
A randomized placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and cystic fibrosis patients.May 2012
To assess the safety and tolerability of single and and multiple doses of QBW251 in healthy subjects and cystic fibrosis patients To evaluate the pharmacodynamic response to multiple doses of QBW251 in cystic fibrosis patients as reflected in changes in lung function (forced expiratory volume in one second, FEV1 - Part4 only)
PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural MesotheliomaMay 2012
The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.
AVAPS-AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD)Patients (AVAPS-AE COPD)May 2012
The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD patients during nocturnal ventilation.
A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial HypertensionMay 2012
To investigate the safety of continuous treatment with sc lisuride infusions as add-on treatment to stable conventional therapy in patients with pulmonary arterial hypertension (PAH).
A Phase II study of the selective BRAF kinase inhibitor GSK2118436 in subjects with advanced non-small cell lung cancer and BRAF mutationsMay 2012
To assess the overall response rate (ORR) in subjects with stage IV or relapsed BRAF V600E mutant non-small cell lung cancer administered GSK2118436 as a single agent.
A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922 in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or - amplification or - mutation.May 2012
To evaluate efficacy of combined trastuzumab and AUY922 in HER2 - overexpressed or - amplified or - mutated NSCLC
Diagnosis community-acquired pneumonia in emergency unitMay 2012
To identify surrogat markes to identify community-acquired pneumonia among adultpatients having lower respiratory tract infection
A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertensionMay 2012
To evaluate the long-term safety and tolerability of the pediatric formulation of bosentan at a dose of 2 mg/kg b.i.d. in children with pulmonary arterial hypertension (PAH).
Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung CancerMay 2012
To determine whether treatment with ADI-PEG 20 will shrink small cell lung cancer.
Ganetespib With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)Apr 2012
Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos. Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath. Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.
A Single Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after TransplantationApr 2012
To show that the variability of whole blood total and unbound plasma tacrolimus concentrations during the first 6 days post transplantation is larger than the variation of tacrolimus concentrations in stable clinical situation.
A phase II, randomized, controlled, partially-blind study to demonstrate immunogenicity and assess safety of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccines (2830929A and 2830930A) administered as a 3-dose primary vaccination course during the first 6 months of life and as a booster dose at 12-15 months of age.Apr 2012
• To demonstrate that 2830929A vaccine co-administered with DTPa-HBV-IPV/Hib as a three-dose primary vaccination course at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA Geometric Mean Concentrations (GMCs). • To demonstrate that 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA GMCs.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR MutationApr 2012
To evaluate the efficacy of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CF transmembrane conductance regulator (CFTR) mutation
A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR MutationApr 2012
To evaluate the safety of long-term ivacaftor treatment in subjects with cystic fibrosis (CF)
A Phase 2, multicenter, double-blinded, placebo-controlled, 3-part study to evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of VX 661 monotherapy and VX 661/VX 770 cotherapy in subjects with cystic fibrosis (CF), homozygous for the F508del-cystic fibrosis transmembrane conductance regulator gene (CFTR) mutationApr 2012
-To evaluate the safety and tolerability of VX 661 monotherapy and VX 661/VX 770 cotherapy -To evaluate the effect of VX 661 monotherapy and VX 661/VX 770 cotherapy on CFTR function
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) Revised Protocol 01 incorporating administrative letter 04 and protocol amendment 04 (dated 09-Feb-2012)Apr 2012
To compare overall survival (OS) of subjects randomized to ipilimumab in addition to platinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum and etoposide (Arm B) in subjects with newly diagnosed extensive stage SCLC.
A randomized, double-blind, placebo-controlled study to determine safety, tolerability and the optimal effective dose of SUBLIVAC FIX Birch in patients with allergic rhinitis/rhinoconjunctivitis caused by birch pollenApr 2012
Determination of the optimal effective dose of SUBLIVAC FIX Birch (SB) based on reduction of upper airways reactivity assessed by TNPT after 5 months of treatment with different dosages of SB compared to placebo. Coprimary objective: Difference in proportions of patients not reaching maintenance dose within 10 days due to related AEs of different dosages of SB compared to placebo.
Acute Upper Respiratory Tract Infection - When is Bacteria Involved?Apr 2012
The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.
A 12-month, open label, randomised, effectiveness study to evaluate fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler compared with usual maintenance therapy in subjects with AsthmaApr 2012
The objective of the study is to compare the effectiveness of fluticasone furoate(FF)/vilanterol (VI) Inhalation Powder (FF 100mcg/VI 25mcg or FF 200mcg/VI 25mcg) with usual asthma maintenance therapy over twelve months in a large UK primary care population of subjects with Asthma. FF/VI will be administered once-daily (QD) via the Novel Dry Powder Inhaler (NDPI).
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung CancerApr 2012
The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.
A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma (SKOPOS)Mar 2012
This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy. We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.
A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 also known as P202)Mar 2012
To compare serious asthma outcomes (a composite endpoint defined as asthmarelated: hospitalizations, intubations, and deaths) in subjects treated with MF/F MDI BID versus subjects treated with MF MDI BID.
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial PneumoniaMar 2012
The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with severe pneumonia or patients who did not respond to other antibiotics used for the treatment of bacterial pneumonia. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.
Determination of the penetration of antibiotics into epithelial lining fluid during continuous infusion in mechanically ventilated ICU patients: example meropenemMar 2012
Determination of penetration of IMPs into the epithelial lining fluid in intensive care unit patients
A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of metmab in combination with either bevacizumab + platinum + paclitaxel or pemetrexed + platinum as first-line treatment in patients with stage IIIb or IV Non-Squamous Non−Small Cell Lung Cancer (NSCLC)Mar 2012
To evaluate the efficacy of MetMAb compared with placebo by PFS in all patients and in the subgroup of patients with Met diagnostic–positive tumors in each of two combination treatment cohorts: Cohort 1: MetMAb + bevacizumab + platinum + paclitaxel vs. placebo + bevacizumab + platinum + paclitaxel Cohort 2: MetMAb + platinum + pemetrexed vs. placebo + platinum + pemetrexed
A phase III contact tracing trial comparing the diagnostic performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in combination with a double blind randomized split body safety assessment of C-Tb versus 2 T.U. Tuberculin PPD RT23 SSIMar 2012
To compare the diagnostic performance of C-Tb to that of QuantiFERON®-TB Gold In-Tube To compare the diagnostic performance of C-Tb to that of Tuberculin PPD RT23 SSI To assess the safety of C-Tb
Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of FormoterolMar 2012
The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination with Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients with Extensive-Stage Small Cell Lung Cancer.Mar 2012
The primary objective of this study is to compare the efficacy of palifosfamide-tris in combination with carboplatin and etoposide (PaCE) chemotherapy to carboplatin and etoposide (CE) alone, as measured by overall survival (OS), in chemotherapy naïve subjects with extensive-stage SCLC.
A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of metmab in combination with paclitaxel + cisplatin or carboplatin as first-line treatment for patients with stage IIIb (T4 disease) or IV squamous non-small cell lung cancer (NSCLC)Mar 2012
To evaluate the duration of progression-free survival of MetMAb + paclitaxel + platinum (cisplatin or carboplatin) relative to placebo + paclitaxel + platinum in all enrolled patients and in the subgroup of patients with Met diagnostic–positive tumors
A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non- Small Cell Lung Cancer (NSCLC) and who previously responded to gefitinib and received subsequent chemotherapy or other active anti-cancer therapy excluding EGFR-TKIsMar 2012
To characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC
Randomized Phase II Study of Cabazitaxel versus Topotecan in Small Cell Lung Cancer Patients with Progressive Disease during or after a First Line Platinum Based ChemotherapyMar 2012
To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in patients with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique DeviceMar 2012
The purpose of this study is to measure daily variability of FOT data measured at home of a group of COPD patients in order to identify possible correlations between symptoms change, breathing pattern, lung mechanical impedance and occurrence of exacerbation.
A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX 23) and Prevnar 13 (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or OlderFeb 2012
1.-To demonstrate that the safety profile of a single dose of V114 is acceptable. 2.-To compare serotype-specific IgG geometric mean concentrations (GMCs), as measured by Merck's pneumococcal electrochemiluminescence (Pn ECL) assay between recipients of a single dose of V114 and a single dose of PNEUMOVAX? 23 for the 14 shared serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F), as measured at 1 month postvaccination.
A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent AsthmaFeb 2012
To demonstrate the dose-related efficacy by evaluating morning lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) after 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of mometasone furoate (MF) metered dose inhaler (MDI) twice a day (BID) compared with placebo in children 5 to 11 years of age, inclusive, with persistent asthma.
A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)Feb 2012
The primary objective is to compare survival rate at 12 months in Vx-001 treated vs placebo treated patients.
Phase II study on the safety and efficacy of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergyFeb 2012
To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of 2 different dose levels of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded during the peak of the grass pollen season of each treatment year.
Tolerance and effect of an add-on therapy with an ivy leaves dry extract syrup on lung function in children with asthma.Feb 2012
To evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change)
A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial HypertensionFeb 2012
The primary objective of this study is to evaluate the safety and tolerability of a rapid dose titration regimen of SC (subcutaneous) Remodulin therapy in patients with PAH. Safety and tolerability of the rapid dose titration regimen will be considered to be demonstrated by all clinical trial subjects that complete the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.
Insulin therapy in non-diabetic adults with cystic fibrosisFeb 2012
This study aims to investigate the effect of low dose insulin therapy on nutritional status en body weight.
Dexamethasone in community-acquired pneumonia.Jan 2012
The effect of dexamethasone on clinical outcome in patients admitted with CAP
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer PatientJan 2012
Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
Individualizing duration of antibiotic therapy in hospitalized patients with community-acquired pneumonia: a non-inferiority, randomized, controlled trial.Dec 2011
Assessment of non-inferiority of duration of individualized antibiotic therapy at clinical stability versus standard duration of therapy.
Evaluation of any steroid sparing effect of beta blocker therapy on airway hyper-responsiveness in stable, mild to moderate, asthmatics.Dec 2011
Do any effects on airway 'twitchiness' in asthma with chronic dosing of beta blockers and low dose steroid inhaler differ with being on a high dose steroid inhaler?
Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower AirwaysDec 2011
The objective of this study is to evaluate safety of treatment with AZLI 75 mg 3 times daily (TID) for 3 courses of therapy (28 days on/28 days off) in female and male children less than 13 years of age with CF and chronic PA infection/colonization.
A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung CancerDec 2011
Evaluation of progression-free survival of subjects following treatment with MEDI-575 when used in combination with paclitaxel/carboplatin versus paclitaxel/carboplatin alone in subjects with previously untreated, advanced non-small cell lung cancer
Cisplatin, Etoposide, and Two Different Schedules of Radiation Therapy in Treating Patients With Limited Stage Small Cell Lung CancerDec 2011
This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease StageDec 2011
Comparison of two combination chemotherapies in the treatment of patients with SLCL
SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.Dec 2011
The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal intubation, and death).
Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patientsDec 2011
The primary objective is to find out, if continuous long-term local application of specific egg yolk antibodies (IgY) directed against PA - initiated after successfully treated acute PA infection - can prolong the time to recurrence of a sputum culture positive for PA. The objective to prevent infections with PA is also to diminish the need of antibiotics and minimize the problem of bacterial resistance against antibiotics.
Duration of Antibiotic Therapy in Community - Acquired Pneumonia (DURATION)Dec 2011
The purpose of the study is to assess the efficacy of an individualized approach to duration of antibiotic therapy based on each subject's clinical response compared to a local standard approach in patients coming from the community and who are hospitalized because of a pneumonia.
LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lungNov 2011
To compare the progression-free survival (PFS) and disease control rate (at 12 months) of afatinib with gefitinib among patients with adenocarcinoma of the lung harbouring activating EGFR mutations who have no prior systemic chemotherapy in advanced setting (stage IIIB or IV)
HZA106853: A dose-ranging study of vilanterol (VI) inhalation powder in children aged 5-11 years with asthma on a background of inhaled corticosteroid therapy.Nov 2011
The primary objective is to evaluate the dose response, efficacy and safety of three doses of VI inhalation powder administered once daily in the evening in children aged 5-11 years with persistent uncontrolled asthma over a 4 week treatment period.
A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial HypertensionNov 2011
Main objective of the trial is to characterize the pharmacokinetics (PK) of tadalafil in a pediatric population with pulmonary arterial hypertension (PAH) to establish an appropriate dose range for further clinical research.
A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthmaNov 2011
The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS alone (FP) in pediatric subjects (age 4-11 years) with persistent asthma.
A double-blind, placebo-controlled, study examining the effect of orally administered QAW039 on sputum eosinophil levels and other efficacy outcomes in patients with sputum eosinophilia and persistent asthmaNov 2011
To demonstrate a statistically significant reduction in sputum eosinophil levels in inadequately controlled, moderate-to-severe asthmatics (GINA 2- 5), with sputum eosinophilia after treatment with QAW039 for 12 weeks compared to placebo.
E-support for Healthcare Processes - ASTHMA (E-ASTHMA)Oct 2011
The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.
A phase I/IIa study of the safety, tolerability and biological effect of single and repeat administration of the selectively replication-competent herpes simplex virus HSV1716 into the tumour-bearing pleural cavity (intrapleural) in patients with inoperable malignant pleural mesothelioma.Oct 2011
The principal research objective is to investigate whether HSV1716 is safe and well-tolerated when administered directly into the cavity that surrounds and protects the lungs (pleural cavity) of patients with a type of cancer that originates from the linings of the pleural cavity (malignant pleural mesothelioma). The study will assess this question in the context of three groups of patients. One group will receive a single dose of HSV1716, the second group will receive two doses and the third group will receive four doses.
Exocrine Pancreatic Function Testing in Cystic FibrosisOct 2011
The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function. The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis. Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of CF may be of therapeutically benefit.
Assessing Decision Maker Tools for Asthma: the Asthma APGAROct 2011
This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide "usual" care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.
Reduce IDentified UNcontrolled Asthma (RIDUNA)Oct 2011
The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of real-time identification of uncontrolled asthma by electronic administrative records linked to real-time notification of uncontrolled status to patients and asthma specialists with recommended guideline directed intervention by physicians. The investigators hypothesize that real-time outreach following National guideline asthma care recommendations, after real-time identification of an uncontrolled asthma event in persistent asthmatics on inhaled corticosteroids will lead to better improvements in asthma control (impairment and risk) compared to standard asthma care outreach.
Prevention of Post-operative Pneumonia (POPP)Sep 2011
Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It leads to considerable morbidity and contributes to perioperative morbidity. There is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically ventilated patients. This study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.
Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma (IHOP)Sep 2011
The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.
Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed after Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility StudySep 2011
To assess the adherence rate to pemetrexed administered in a domiciliary setting.
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung CancerSep 2011
Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at < 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) versus BSC Alone in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer RegimensSep 2011
Compare the overall survival (OS) of patients receiving E7080 + BSC with those receiving placebo + best supportive care (BSC)
STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trialAug 2011
To compare the time it takes for the patient's cancer to get worse (tumour gets bigger) when treated with olaparib, as opposed to those patients that receive placebo.
Effect of Glycine in Cystic FibrosisAug 2011
The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5 g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis, as compared with placebo. During all of the study children will receive their usual treatment for cystic fibrosis.
Trial of pasireotideLAR and Topotecan in Relapsed or Refractory Small Cell Lung CancerAug 2011
The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type 1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF which is known to contribute to SCLC proliferation. Topotecan is approved for second line therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents should yield greater antitumor activity.
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe PneumoniaJul 2011
This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.
A Phase III, open-label, multicentre, randomised trial to establish safety and efficacy of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive careJun 2011
To assess overall survival (OS) of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients when compared to the control group receiving best treatment and supportive care.
Control of moderate or severe asthma with 160, 320 and 640μg ciclesonide/day. A one-year randomised, double-blind, multicenter trial.Jun 2011
The aim of the trial is to investigate whether long-term treatment with 320 and 640μg ciclesonide/day for one year improves asthma control in subjects with lack of asthma control while on 160μg ciclesonide/day. Additionally, the trial will provide further data on the long-term safety and tolerability of ciclesonide.
Early access of TMC207 in combination with other anti-tuberculosis (TB) drugs in subjects with extensively drug resistant (XDR) or pre-XDR pulmonary TBJun 2011
The primary objective is to provide early access to TMC207 for subjects who have pulmonary infection due to strains of M. tuberculosis with resistance to INH, RMP, and to a fluoroquinolone (FQ) and/or injectable 2nd line TB drug(kanamycin, amikacin, or capreomycin).
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe AsthmaMay 2011
To evaluate two SC treatment regimens of 300 mg tralokinumab compared with placebo by assessing the effect on asthma exacerbation rate over 52 weeks in adults with uncontrolled, severe asthma requiring high-dose ICS and LABA with or without additional asthma controller medications.
Costimulatory Molecules as Biomarkers in Cystic FibrosisMay 2011
The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.
A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY)May 2011
A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
Rasagiline treatment for Sleep disorders in Parkinson´s diseaseApr 2011
Reduction of sleep disturbances
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung CancerApr 2011
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
The pharmacokinetic effect of clarithromycin on the AUC0-12h of linezolid in multidrug-resistant and extensively drug-resistant tuberculosis patientsApr 2011
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA).
Prospective randomised controlled trial of video assisted thorascopic (VATS) cytoreductive pleurectomy compared to talc pleurodesis in patients with suspected or proven malignant mesotheliomaApr 2011
The principal aim of this study is to compare the effectiveness of video-assisted thoracoscopic (VAT) cytoreductive pleurectomy against talc pleurodesis for patients with pleural effusion secondary to mesothelioma We have chosen pleurodesis with talc (either via an intercostal chest drain or during thoracoscopy) as the principal control group because these are widely available and commonly used treatments for management of malignant pleural effusion. The Primary objective is to compare the effectiveness of talc pleurodesis against video-assisted thoracoscopic cytoreductive surgery in terms of survival at one year.
Influence of an Asthma Education Programme on Asthma Control During PregnancyApr 2011
Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.
Predicting Response to Azithromycin Therapy in AsthmaMar 2011
The purpose of this study is to better understand the mechanistic effects of Azithromycin (AZM) in asthma, and to establish if AZM therapy is effective in a subgroup of patients with chronic asthma who have phenotypically distinct disease
A phase II trial to assess the safety, immunological activity of Trovax plus Pemetrexed/ Cisplatin in patients with malignant pleural mesothelioma.Mar 2011
To evaluate whether TroVax® is active in the treatment of MPM. This will be assessed by measuring the cellular or humoral anti-5T4 immune responses following treatment with TroVax® given in combination with Pem/Cis.
Operational Research Management for Children With Severe Pneumonia (OR-pneumonia)Mar 2011
The investigators Study Hypothesis is introduction of modified IMCI guideline for managing severe pneumonia in first level health facilities will result in 40% increase in the appropriate management (appropriate case management at the first level facility and referral compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to the comparison arm.
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non–Small-Cell Lung Cancer (NSCLC)Mar 2011
The primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.
What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?Feb 2011
To assess the clinical value of using intravenous iron (ferric carboxymaltose) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension. The primary endpoint will be the change in the resistance to blood flow through the lungs (resting pulmonary vascular resistance), measured by cardiac catheterisation at baseline and 12 weeks after the initial infusion.
NGR019: Randomized double-blind phase II study of NGR-hTNF versus placebo as maintenance treatment in advanced malignant pleural mesothelioma (MPM)Feb 2011
To compare progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia (IMIEPAP)Jan 2011
The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.
Smoking young asthmatics: Change of inflammation and quitting cessation rate – effect of ChampixJan 2011
Research of changes in the asthmatic bronchial inflammation before and after tobacco cessation. Success rate of Champix in young asthmatics.
A phase II trial of the addition of ipilumimab to carboplatin and etoposide chemotherapy for the first line treatment of extensive small cell lung cancerJan 2011
The trial aims to answer whether the addition of Ipilumimab to carboplatin and etoposide chemotherapy for patients with extensive stage small cell lung cancer is able to improve outcome for these patients as assessed by the proportion of patients alive and without progression at 1 year.
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (GLITZ Asthma)Jan 2011
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics. Researchers believe this occurs because excess adipose tissue (fat) in the body can cause higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood. The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung CancerDec 2010
To determine if treatment with AMG 706 in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).
A study of erlotinib (Tarceva®) treatment in patients with locally advanced or metastatic Non-Small Cell Lung Cancer who present activating mutations in the tyrosine kinase domain of the epidermal growth factor receptorDec 2010
Efficacy of erlotinib (TarcevaTM; 150 mg) on progression-free survival (PFS) in patients with non-small-cell lung cancer (NSCLC) in locally advanced or metastatic stages (stage IIIB and stage IV) who have not received previous chemotherapy for their disease and who present activating mutations in the tyrosine kinase (TK) domain of the epidermal growth factor receptor (EGFR).
A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies.Nov 2010
Phase 1: The primary objective of the phase 1 portion of this study is to assess the safety and tolerability of MLN8237, formulated as an enteric-coated tablet (ECT), on a 7-day dosing schedule for determining the recommended dose and schedule of MLN8237 to be used in phase 2. Phase 2: The primary objective of the phase 2 portion of this study is to estimate the antitumor activity of MLN8237 as measured by overall response rate (ORR) in patients with advanced, unresectable nonhematological malignancies (NSCLC, SCLC, adenocarcinoma of the breast, HNSCC, or adenocarcinoma of the esophagus/gastroesophageal junction or stomach).
The pharmacogenetics of vitamin D response in tuberculosisNov 2010
The primary outcome will be the interaction between vitamin D binding protein genotype (GC genotype) and pre-supplementation vitamin D level in determining post-supplementation vitamin D level
Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel (NSCLC)Nov 2010
The purpose of this study is to examine the overall survival of patients with Stage IV non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin and paclitaxel.
A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI 906 plus Erlotinib (Tarceva®), or Erlotinib plus Placebo in Patients with Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLCOct 2010
The primary objective of this study is to determine the progression free survival (PFS) of maintenance OSI-906 plus erlotinib (Arm A), or erlotinib and placebo (Arm B) in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC.
NGR015: Randomized double-blind phase III study of NGR-hTNF plus best investigator’s choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM)Oct 2010
To compare overall survival (OS) in patients randomized to NGR-hTNF plus BIC (Best Investigator Choice) versus patients randomized to placebo plus BIC
Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosisOct 2010
The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX
Randomised, multi-centre, double-blind, placebo-controlled trial of vitamin d supplementation in adult and adolescent patients with asthmaOct 2010
Does vitamin D supplementation influence time to first severe exacerbation and time to first upper respiratory tract infection in patients with asthma?
QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study. (OPTIMIST)Oct 2010
The aim of the study is to compare a combined strategy of the TST and the QFT-IT with TST alone for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing study
Phase 2 Study of CS-7017 and Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer Who Failed First Line TherapyOct 2010
To estimate the difference in efficacy, as measured by progression-free survival (PFS), between erlotinib in combination with CS-7017 and erlotinib alone.
A Phase 2, Multicenter, Double Blinded, Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of VX-809 Alone and in Combination with VX-770 in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationOct 2010
To evaluate the safety and tolerability when VX-809 is administered alone and when VX-809 is coadministered with VX-770. To evaluate the effect of VX-809 administered alone and VX-809 coadministered with VX-770 on sweat chloride.
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive StrategySep 2010
The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer (NSCLC) "driven" by epigenetic changes. The investigators study the impact of 5-azacitidine (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy in a sequential fashion. The study population consists of all NSCLC patients who undergo "curative" lung cancer resection and whose tumors harbor hypermethylation in any of the protocol-specific genes (samples will be banked for additional molecular testing including other 21 loci which have shown to be important in lung carcinogenesis.
Betablocker Therapy in Pulmonary Arterial HypertensionAug 2010
The main question of this study is: ‘Is selective beta-blocker treatment safe and effective in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients with iPAH?‘ Safety of Bisoprolol treatment in iPAH patients is not taken as a primary endpoint but seen as a precondition for this study and will be closely monitored. Dose titration will be guided by possible side effects. Furthermore, although beta-blocker are considered contraindicated in PAH patients, a considerable number of patients frequently receives beta-blocker therapy in an uncontrolled way (3), without any side effects being reported until now.
Phase II study of cetuximab combined with cisplatin or carboplatin/pemetrexed as first line treatment in patients with malignant pleural mesothelioma.Jun 2010
To investigate the activity and safety of the combination of cetuximab and platinum/pemetrexed as first line treatment in EGFR IHC positive mesothelioma patients.
A Randomised Stratified Multicentre Phase II Clinical Trial of Single-Agent ADI-PEG 20 (Pegylated Arginine Deiminase) in Patients with Malignant Pleural Mesothelioma.Jun 2010
To assess the time to disease progression between the control group receiving best supportive care and the group receiving ADI-PEG 20 and best supportive care.
A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®May 2010
To determine the long-term safety and efficacy of inhaled Nacystelyn®, in the presence or absence of rhDNase, in patients with CF as reflected in a change per treatment group in the time to first pulmonary exacerbation (PE) during the study period.
Promoting Asthma Wellness in Rural CommunitiesMay 2010
This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth: 1. Improving adherence to asthma controller medication use; 2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms; 3. Improving inhaler technique; 4. Smoking reduction or cessation in those who are smokers; and 5. Avoidance of second-hand smoke exposure.
Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial.Apr 2010
To determine the toxicity of adding chloroquine in escalating doses in SCLC patients: to standard dose cisplatin-etoposide in extensive disease SCLC = STEP 1, and - to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC = STEP2
An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic FibrosisApr 2010
To evaluate the safety of long-term VX-770 treatment in subjects with cystic fibrosis (CF)
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients (DOXY)Apr 2010
The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.
Small Particle Inhaled Steroids in Refractory Steroid-responsive AsthmaMar 2010
In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation? The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks.
Evaluation of Beta Blockers for the Treatment of Asthma. A randomised controlled trial of propranololMar 2010
To establish whether chronic dosing with beta-blockers reduces airway inflammation in mild-to-moderate asthmatics on inhaled corticosteriods.
The predictive value of the acute effect of beclomethasone on a mannitol challenge test for the outcome of lomgterm treatment with beclomethasoneMar 2010
What is the correlation between change in Mannitol PD15 (provoking dose of mannitol to cause a ≥ 15% fall in FEV1 ) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)Jan 2010
The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.
The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukastDec 2009
What is the correlation between change in % fall in FEV1 (∆FEV1) after an exercise challenge 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast?
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)Dec 2009
This single arm study will assess the safety and efficacy of Endostar combined with chemotherapy (Gemcitabine plus Platinum-based chemotherapy) followed by Endostar maintenance therapy in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
Latent Tuberculosis Infection in Bone Marrow Transplant RecipientsNov 2009
The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.
MIMEB - Molecular Imaging with erlotinib and bevacizumab. A Phase II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET and DCE-MRI for Early Prediction of Non-Progression in Patients with Advanced Non Squamous Cell Non Small Cell Lung Cancer (NSCLC) treated with Erlotinib and Bevacizumab and to Associate Imaging Findings with Molecular MarkersSep 2009
To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of RECIST-based non-progression (CR+PR+SD) after 6 weeks of therapy in patients with NSCLC stage IIIb/IV treated first line with erlotinib and bevacizumab. To evaluate the accuracy of imaging findings in FDG-/FLT-PET and DCE-MRI after one week of treatment for early prediction of PFS in patients with NSCLC stage IIIb/IV treated first line with erlotinib and bevacizumab.
Impact of Aerobic Exercise on Asthma Morbidity (Ex-Asthma)Aug 2009
The current proposed study will assess the effects of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual medical care, 52 patients will participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain usual medical care. The asthma control, quality of life, and inflammatory profile will be evaluated at baseline and following the 12 weeks of treatment. The investigators believe that: (1) The exercise intervention will significant improve asthma control and asthma quality of life; (2) The exercise intervention will result in significant improvements in inflammatory profiles; and (3) These changes in the inflammatory profile will be directly related to the improvements in asthma control and quality of life.
Evaluation of the safety and efficacy of WST11 mediated vascular targeted photodynamic therapy on obstructing endobronchial Non-Small Cell Lung CancerJul 2009
To determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using vascular targeted photodynamic therapy (VTP) in obstructive non-small cell lung cancer.
A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D MutationJul 2009
Part A: To evaluate the pharmacokinetics of a single dose of orally administered VX 770 treatment in subjects 6 to 11 years of age with cystic fibrosis (CF) who have the G551D cystic fibrosis transmembrane conductance regulator (CFTR) mutation on at least 1 allele. Part B: To evaluate the efficacy of VX 770 after 24 weeks of treatment in subjects 6 to 11 years of age with CF who have the G551D CFTR mutation on at least 1 allele.
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (GERD-BPD)Jun 2009
The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to TreatmentJun 2009
Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as calcium and phosphate. There is new information that links vitamin D to the functioning of our immune system. The purpose of the study is to find out how vitamin D affects the immune system of patients with TB. We want to find out if correcting low vitamin D levels, in addition to getting standard therapy for TB, will help the immune system fight off TB infection more effectively. The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family members or household contacts of patients with tuberculosis will be participating in this study. TB patients, already receiving standard TB therapy, will be randomly assigned to either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the subject nor the investigator will know whether the subject has received the Vitamin D or the inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks( during out-patient visits to the hospital). The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D MutationJun 2009
To evaluate the efficacy of VX 770 after 24 weeks of treatment in subjects with cystic fibrosis (CF) who have the G551D cystic fibrosis transmembrane conductance regulator (CFTR) mutation on at least 1 allele.
A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide with or without Obatoclax Administered Every 3 Weeks to Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)May 2009
Phase I: Determine the recommended Phase II dose of obatoclax administered as a 3-hour infusion on 3 consecutive days and, in a separate obatoclax dose escalation, as a 72-hour infusion, every 21 days in combination with carboplatin and etoposide. Phase II: Compare the overall response rate of the 2 treatment arms (• Carboplatin, etoposide, and obatoclax as a 3-hour infusion on 3 consecutive days, or • Carboplatin and etoposide alone)
Effect of macrolides on asthma control, airway inflammation and bacterial colonisation in smokers with asthmaApr 2009
This randomised controlled trial will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.
A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)Mar 2009
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC) (SBRT-NSCLC)Mar 2009
The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.
A Randomized Discontinuation Phase II Trial of Deforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients with KRAS MutationsMar 2009
To determine the efficacy of deforolimus in patients with KRAS mutant NSCLC who have progressed after two prior chemotherapy regimens compared to placebo by progression free survival analysis of randomized patients who have stable disease after an 8-week lead-in treatment with deforolimus.
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyMar 2009
To determine whether inhaled mannitol compared to control improves FEV1 in patients with Cystic Fibrosis.
Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)Mar 2009
Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough. The investigators hypothesize that: Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group. Also children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.
Parents, Pediatricians, and Asthma Telephone Coaches Partner to Improve Control of Asthma in Children (The PARTNER Study)Mar 2009
Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.
Concomitant Tarceva® and irradiation in patients in local-regionally advanced non-small cell lung cancer. A phase II studyJan 2009
The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week)
Effect of montelukast on levels of metalloproteinase-9 (MMP-9), MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen peptide type 1 C-terminal (PICP) and TGF-beta1 on induced sputum of children suffering from intermittent asthma.Dec 2008
To evaluate if 4-weeks treatment with montelukast in children affected by intermittent asthma can significantly reduce levels of TIMP-1 on induced sputum.
Cisplatin and docetaxel followed by short-course of radiotherapy and consolidation chemotherapy with ciplatin and docetaxel in inoperable non small cell lung cancer (NSCLC-stage III).Dec 2008
The primary end-point of this study is to evaluate the activity of the Cisplatin/Docetaxel in association with short-course of radiotherapy in patients with locally advanced and inoperable NSCLC.
Exercise-Induced Bronchospasm in Cystic FibrosisDec 2008
Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has been associated with better patient outcomes and quality of life. Exercise-induced bronchospasm is a condition, often associated with asthma, which may make exercise difficult. The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown. This study is designed to determine how often exercise-induced bronchospasm occurs in cystic fibrosis.
Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a "sensitive" relapseOct 2008
To assess the therapeutic activity of sunitinib in patients with extensive disease small cell lung cancer who are either chemonaïve or have a sensitive relapse.
Multicenter phase III randomized study of cisplatin and etoposide with or without bevacizumab as first-line treatment in extensive stage (ED) small cell lung cancer (SCLC)Oct 2008
To compare overall survival (OS) between the combination cisplatin (25 mg/m2 i.v. on day 1-3) + etoposide (100 mg/m2 i.v. on day 1-3) + bevacizumab (7.5 mg/kg i.v. on day 1) given every 3 weeks (experimental arm) and cisplatin (25 mg/m2 i.v. on day 1-3) + etoposide (100 mg/m2 i.v. on day 1-3) alone given every 3 weeks (control arm) in previously untreated patients with extended SCLC.
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the LungSep 2008
The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).
PPAR-gamma: A noval therapeutic target for asthmaJul 2008
To test the hypothesis that stimulation of the PPAR-gamma receptor has a therapeutic role in the treatment of asthma
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer (RASTEN)Jul 2008
The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.
Sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in locally advanced or metastatic Non Small-Cell Lung CancerJul 2008
To determine time to disease progression of sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in patients with locally advanced or metastatic NSCLC not previously treated with chemoterapy
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic TherapyJun 2008
A phase II study of combination therapy of carboplatin -gemcitabine plus bevacizumab beyond progression in patients with locally advanced and/or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy.
Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung CancerJun 2008
The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when combined with carboplatin plus etoposide. The Phase II portion is to determine progression-free survival among patients with extensive disease small cell lung cancer receiving carboplatin plus etoposide with vorinostat.
A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.Jun 2008
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 μg q.d. and 5 μg q.d.) compared to placebo administered via the Respimat® device on lung function in patients with CF.
Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trialMay 2008
To assess the impact of glutamine supplementation on markers of infection and lung function in patients with cystic fibrosis and previous pseudomonas infection
Phase III Randomized Study of Sunitinib Malate as Maintenance Therapy in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Combination ChemotherapyMay 2008
To compare the effect of sunitinib malate vs placebo on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer who have stable or responding disease after prior treatment with 4 courses of platinum-based therapy.
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line ChemotherapyMay 2008
The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/square metre administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan (1.5 mg/square metre administered as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course) in patients with extensive or limited and sensitive or refractory small cell lung cancer (SCLC) after failure of first-line chemotherapy.
Macrolides in Refractory AsthmaMay 2008
To determine whether macrolides improve bronchial hyperresponsiveness in patients with refractory asthma
An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)Apr 2008
To determine the efficacy of 0.10 mg/kg and 0.25 mg/kg ABT-869 using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and to establish the safety/tolerability profile of ABT-869 in subjects with advanced or metastatic NSCLC.
A randomized phase III study of follow up with or without adjuvant Gefitinib (IressaTM) following chemotherapy in patients with advanced non-small cell lung cancerMar 2008
To demonstrate in a prospective way a benefit in terms of overall survival and progression-free survival of Gefitinib (ZD1839, IressaTM) compared to placebo in patients with advanced non small cell lung cancer (NSCLC), who are not progressing on first line palliative induction chemotherapy.
A randomized phase III study of standard treatment +/- enoxaparin in small cell lung cancerFeb 2008
The primary objective with the study is to evaluate treatment with chemotherapy with a platinum- and a topoisomeras inhibitor containing regimen versus treatment with the same chemotherapy with addition of enoxaparin comparing overall survival.
Pharmacogenomics in Pulmonary Arterial HypertensionJan 2008
Our goal is to determine clinically in Pulmonary Arterial Hypertension patients if associations exist between the efficacy and toxicity of sitaxsentan, bosentan, and ambrisentan and several gene polymorphisms in several key disease-specific and therapy specific genes. Also characterized is the relationship between these polymorphisms and the severity of Pulmonary Arterial Hypertension using either baseline hemodynamic or clinical surrogates for disease severity. Hypothesis: Polymorphisms influence the efficacy and toxicity of specific Pulmonary Arterial Hypertension therapy as well as development/severity of PAH via their effect on PA remodeling, drug response, or metabolism. This study requires a one time 8.5 ml blood sample and clinical data to be obtained at initiation of therapy, 4 months after initiation of therapy and 12 months after initiation of therapy.
A Randomized, Double-Blind, Parallel, Three Arm, Multicenter, Phase II Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination with Taxol®/Paraplatin® (Paclitaxel/Carboplatin) Compared to Taxol®/Paraplatin® Alone in Previously Untreated Subjects with Lung CancerNov 2007
To compare the immune-related progression free survival (irPFS) of subjects receiving ipilimumab in combination with concurrent Taxol®/Paraplatin® (“concurrent”; Arm A) to that of subjects receiving Taxol®/Paraplatin® alone (Arm C) in Stage IIIb/IV NSCLC subjects using irRC as per the assessment of an independent review committee (IRC).
Lung Penetration Of Caspofungin Into Epithelial Lining FluidOct 2007
To determine concentrations of caspofungin in the epithelial lining fluid (ELF) compared to the plasma concentration of caspofungin in patients with fungal infection.
Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosisJul 2007
The main objective is to determine the improvement or worsening lt; 2 of FEV1 in front of 18 months precedents the enrolnment.
Randomized Phase III Trial to evaluate the effect of statins on tumour biology in non-small cell lung cancer.Jun 2007
The primary objective is to evaluate and compare changes in tumour cell proliferation measured through tumour Ki-67 expression following treatment with pravastatin or lovastatin.
Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and skeletal metastased experiencing moderate to severe bone pain.May 2007
The primary objective is to establish the efficacy of ibandronic acid in patients with lung cancer and painful metastatic bone disease and pain responses over a 7 day period.
A phase II study of docetaxel/carboplatin as secondline treatment in patients with refractory or relapsed SCLCApr 2007
To evaluate the response rate of Docetaxel/Carboplatin regimen in patients with refractory or relapsed SCLC.
Risk of Asthma in Infants With Atopic DermatitisApr 2007
Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.
Peripheral targeting of inhaled rhDNase in stable CF patients.Apr 2007
To investigate the effect of treatment with nebulized rhDNase targeted to the peripheral airways compared to rhDNase targeted to the central airways on FEF75 (a lung function parameter for peripheral airflow limitation) in children with CF who are on maintenance treatment with rhDNase.
An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosisMar 2007
The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen.
Long-term, open-label, multicenter extension study of bosentan in patients with pulmonary hypertension associated with sickle cell disease completing a double-blind ASSET study (AC-052-368 or AC-052-369)Jan 2007
To assess long-term safety, tolerability and efficacy of bosentan in patients with pulmonary hypertension (PH) associated with sickle cell disease (SCD)
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Small Cell Lung Cancer (SCLC) or other non-hematological malignancies.Oct 2006
Phase 1: safety assessment, dose limiting toxicity 9DLT) determination, maximum tolerated dose (MTD) determination, pharmacokinetic profile evaluation. Phase 2: safety assessment at the recommended Phase 2 dose (RPTD), preliminary efficacy assessment.
A Phase II Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung Cancer that is Refractory or Progressive within 90 Days of Completion of First-Line Platinum-based ChemotherapySep 2006
The primary objective of the study is the objective tumour response rate (RECIST).
To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosisSep 2006
To establish whether vitamin K supplementation in adolescent and adult patients with CF improves markers of bone formation.
Randomized Phase II Study of Amrubicin as Single Agent or in Combination with Cisplatin versus Etoposide-Cisplatin as first-Line Treatment in Patients with Extensive Stage SCLCJul 2006
The primary endpoint of the study is the overall response rate.
A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke CigarettesFeb 2006
To compare the treatment effect of montelukast 10 mg vs. placebo in asthmatic patients who smoke cigarettes, over a 6 month treatment period on the percentage of asthma-control days.