Novartis announces positive results from phase III PALLADIUM study of inhaled combination QMF 149 in patients with uncontrolled asthma.

Novartis announced that investigational, once-daily, fixed-dose inhaled QMF 149 (indacaterol acetate and mometasone furoate or IND/MF) was superior to mometasone furoate (MF) in improving trough forced expiratory volume in one second (FEV1) after 26 weeks, meeting the primary endpoint of the Phase III PALLADIUM clinical trial. This superior improvement in lung function was achieved in patients with asthma who remain uncontrolled on treatment with inhaled corticosteroid (ICS) at medium or high dose, or long-acting beta agonist (LABA)/ICS at low dose. IND/MF was generally well tolerated, and safety was comparable across treatment arms.

The key secondary endpoint, improvement in Asthma Control Questionnaire (ACQ-7), was also met for combined doses of IND/MF when compared to combined doses of MF, with a statistically significant improvement of asthma control achieved from baseline at Week 26. The PALLADIUM study was conducted to evaluate the efficacy and safety of medium and high doses of QMF 149 (150/160 �g and 150/320 �g) delivered via the dose-confirming Breezhaler device versus two respective medium and high doses of MF (400 �g and 800 �g) delivered via Twisthaler in patients with asthma who were uncontrolled on medium or high dose ICS or low dose LABA/ICS (as determined by pulmonary function testing and effects on asthma control). The PALLADIUM study also included an additional secondary comparison of high dose IND/MF delivered via the dose-confirming Breezhaler device with twice daily salmeterol xinafoate/fluticasone propionate (50/500 �g) delivered via the Accuhaler.

�Nearly half of all patients with moderate-to-severe asthma remain uncontrolled and continue to suffer with regular symptoms and exacerbations,� said Dr. Richard van Zyl-Smit, Associate Professor, Head of the Lung Clinical Research Unit, University of Cape Town Lung Institute, and Consultant Pulmonologist, Groote Schuur Hospital, Cape Town, South Africa. �Promising results from PALLADIUM in both doses of the indacaterol and mometasone furoate combination provide evidence for the efficacy and safety profile of QMF 149 for the treatment of asthma. If approved, the easy-to-use, dose-confirming, once-daily device adds an additional and important option for clinicians treating asthma. I believe that this new fixed-dose combination has the potential to improve and simplify the lives of many patients with uncontrolled asthma.�

The overall incidence of adverse events (AEs) and serious AEs in PALLADIUM was comparable among treatment groups and consistent with the known safety profile of the monocomponents.

About the PALLADIUM Study : PALLADIUM is a multicenter, randomized, 52-week treatment, double-blind, triple-dummy, parallel-group study, to assess the efficacy and safety of the indacaterol acetate and mometasone furoate (IND/MF) combination compared with mometasone furoate (MF) alone in patients with asthma. The purpose of the trial is to evaluate the efficacy and safety of two different doses of IND/MF (150/160 �g and 150/320 �g delivered via Breezhaler) compared with two respective MF doses (400 �g and 800 �g) delivered via Twisthaler (total daily dose) in patients with uncontrolled asthma. All patients were required to be on a stable dose of medium or high dose inhaled corticosteroids (ICS), or low dose long-acting beta agonist (LABA)/ICS for at least 1 month prior to entering into the run-in period. 2216 male and female patients (including 107 adolescents, aged >=12 to <18 years old) were randomized to receive either ind mf 150 160 �g delivered via breezhaler (n="439);" ind mf 150 320 �g delivered via breezhaler (n="445);" mf 400 �g delivered via twisthaler (n="444);" mf 800 �g delivered via twisthaler (n="442);" or salmeterol xinafoate fluticasone propionate 50 500 �g delivered via accuhaler (n="446).he" primary endpoint was to demonstrate the superiority of qmf149 delivered via breezhaler� to mf delivered via twisthaler� in terms of trough fev1 after 26 weeks of treatment in patients with asthma. the primary endpoint was to demonstrate the superiority of qmf 149 delivered via breezhaler to mf delivered via twisthaler� in terms of trough fev1 after 26 weeks of treatment in patients with asthma.>