The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in AdultsMar 2013
In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE. The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults. Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?
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
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.
Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.Feb 2013
The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).
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)
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)Jan 2013
The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
Application of FSME-Immun® and Epaxal® in allergic patientsJan 2013
To assess the humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster
Emollients in the Management of Atopic DermatitisJan 2013
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food AllergyJan 2013
Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date. Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).
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
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in ChildrenJan 2013
The main objective is to investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.
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)
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 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 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.
Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts? (ProNut)Dec 2012
The aim of this study is to identify, based on standardized food provocation tests, which nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of other food allergies or a history of a severe previous reaction
Emollients in the management of atopic dermatitis in children: prevention of flares.Nov 2012
To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.
Prevalence of Food Allergies to Proteins From Different LegumesNov 2012
The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.
In-vivo biological standardization of Dermatophagoides, Betulaceae and Graminaceae extracts for the determination of the biological activity in HEP unitsOct 2012
Determination of the biological activity of allergenic extracts of Dermatophagoides, Betulaceae and Graminaceae in HEP units (histamine equivalent prick) in order to define an in-house reference preparation (IHRP).
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
A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic DermatitisOct 2012
To compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate dermatitis
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 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
Biological standardization of Chenopodium album allergen extract to determine the biological activity in HEP units.Aug 2012
The primary objective is to assess the concentration of Chenopodium album allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.
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.
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.
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.
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).
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).
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 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.
A randomized, double-blind, parallel-group, placebo-controlled study to assess the safety of REGN668 administered concomitantly with topical corticosteroids to patients with moderate-to-severe Atopic dermatitisApr 2012
The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).
A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic DermatitisApr 2012
The primary objective is to establish the therapeutic equivalence between tacrolimus ointment 0.1%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.1% topical ointment manufactured by Astellas Pharma B.V., The Netherlands and marketed by Astellas Pharma Europe Ltd. and to show superiority over vehicle in the treatment of moderate to severe Atopic Dermatitis in adult population.
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.
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 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 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.
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)
Mechanistic study assessing the immunological response of subjects after treatment with different formulations of sublingual immunotherapy.Jan 2012
To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U.
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?
A randomized, double-blind, placebo-controlled, repeat-dose study of the efficacy, safety, tolerability, and pharmacodynamics of subcutaneously-administered REGN668 in adult patients with extrinsic moderate-to-severe atopic dermatitisDec 2011
The primary objective is to assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).
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).
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 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 double blind placebo controlled randomised trial to study the effects of birch pollen specific immunotherapy (BP-SIT) on the symptoms of the oral allergy syndrome in adult patients.Oct 2011
Does immunotherapy (the process of giving small but increasing doses of birch pollen as injections under the skin) improve symptoms of mouth and throat itch, irritation and swelling on eating apples in patients with oral allergy syndrome?
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.
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.
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton SyndromeAug 2011
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).
Interferon Responses in Eczema Herpeticum (ADEH) (IFN)Jul 2011
Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin infections. A small subset of patients with AD suffer from disseminated viral infections, e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum (EV) after smallpox vaccination. Interferon (IFN)-γ plays a critical role in the innate and acquired immune responses by activating macrophages, enhancing natural killer cell activation, and promoting T cell differentiation, as well as regulating B cell isotype switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFN-γ generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFN-γ induction leads to susceptibility to HSV infection in ADEH+ patients.
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.
Comparison of Moisturisers for the Prevention of Atopic Dermatitis Relapse– a Randomised, Double Blind Controlled Study (COMPADRE)Jun 2011
The primary objective is to show that a barrier strengthening moisturiser is superior to a base cream in preventing eczema relapse in patients with AD.
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.
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczemaApr 2011
To determine if anti-IgE can improve very severe eczema in children, who have not responded to the usual 1st and 2nd line treatments for eczema (assessed by the eczema severity score, SCORAD), as compared to a placebo.
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
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.
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.
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?
Proof of concept study of combined allergen immunotherapy and antibiotics for the treatment of chronic atopic eczemaOct 2010
To test whether combined antibiotics and allergen-immunotherapy (desensitisation to the allergen house dust mite) lead to clinical improvement in adults with severe atopic eczema.
Evaluate Reversal of Pathological Epidermal Phenotype in Severe Atopic Dermatitis (AD) With Suppression of Immune Activation During Cyclosporine A TherapyJun 2010
Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects 1-3% of the adults and up to 25% of the children in the United States. Patients with severe AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form) to evaluate the immune suppression and pathological correlation of cyclosporine A in these patients in order to determine the extent to which immune activation drives the pathological epidermal phenotype.
Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma.Jun 2010
The primary objective of the trial is to evaluate the efficacy of the the house dust mite Allergy Immunotherapy Tablet (6 DU and 12 DU) given once daily compared to placebo in subjects with house dust mite induced asthma, as measured by reducing the risk for an asthma exacerbation.
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.
A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic DermatitisMay 2010
To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children.
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?
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?
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.
A multicenter, randomized, intra-individual, double blind, vehicle-controlled study to evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks in the treatment of target lesions in adults subjects with atopic dermatitisMay 2009
To evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks versus its vehicle on target lesions in adult subjects with Atopic dermatitis.
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.
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.
A multi-centre, double-blind, placebo-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.Jan 2009
To evaluate the efficacy and safety of topically applied Altoderm in the treatment of atopic dermatitis in children.
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.
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind studyAug 2008
To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.
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
Macrolides in Refractory AsthmaMay 2008
To determine whether macrolides improve bronchial hyperresponsiveness in patients with refractory asthma
Studies of Skin Microbes in Healthy People and in People With Skin ConditionsJan 2008
This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial in 25 patients with moderate atopic dermatitis to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of twice daily topical applications with 10% ImCOOH cream for 14 days with an additional morning application on Day 15.Nov 2007
Main objectives of the trial are to determine the efficacy of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis; and to determine the safety and tolerability of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis.
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.Sep 2007
The primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis.
Double-Blind, Randomised, Active And Placebo Controlled Study To Assess The Clinical Efficacy, Skin Tolerability And Pharmacological Activity Of A New Topical Compound (Ur-1505 0.5%, 1% And 2%) In Patients With Mild To Moderate Atopic DermatitisJun 2007
To explore the clinical efficacy of UR-1505 (0,5%, 1% and 2%) applied once daily during 4 weeks, compared with a vehicle without active ingredients and with an active treatment, in adult patients with mild to moderate atopic dermatitis.
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.
LEO19123 Cream in the Treatment of Atopic Dermatitis A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitisJan 2007
To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.
A study to evaluate the role of tacrolimus ointment (Protopic®) 0.1% in the treatment of chronic otitis externa.Dec 2006
To establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment.
A two months study of the utility of Elidel cream 1% (pimecrolimus) in the long term management of atopic hand eczema.Aug 2006
To investigate if an Pimecrolimus (pimecrolimus) based treatment regime prolongs the time to relapse after control of a flare compared with a treatment with Pimecrolimus vehicle plus emollients in patients with chronically relapsing atopic hand eczema.
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.