Patients With Severe COPD Show Significant Improvements in Dyspnea and Lung Function With Once-Daily QVA149: The Blaze Study

Abstract

SESSION TITLE: COPD QVA149 PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: Patients with severe COPD experience marked deterioration in lung function and breathlessness compared to patients with mild-to-moderate COPD. We report improvement of dyspnea and lung function in patients with severe COPD in the BLAZE study with QVA149, a dual bronchodilator combining the long-acting [beta]2-agonist (LABA) indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237), versus placebo and tiotropium. METHODS: In this 6-week, multicenter, blinded, placebo-controlled, 3-period, crossover study, patients aged >=40 years with moderate-to-severe COPD were randomized to QVA149 110/50ug or tiotropium 18 ug or placebo. Improvements in patient-reported dyspnea via the innovative self-administered computerized (SAC) Baseline and Transition Dyspnea Index (BDI/TDI) and FEV1 AUC0-4h were assessed. RESULTS: 78 (31.6%) of the 247 patients randomized had severe COPD. The percentage of patients with severe COPD achieving >=1 point improvement in SAC-TDI total score was higher with QVA149 (41.7%) compared with tiotropium (30.0%; odds ratio 1.66; p=0.185) and placebo (21.7%; odds ratio 2.98; p=0.007). QVA149 provided rapid bronchodilation, with statistically significant (p0.001) improvements in FEV1 AUC0-4h versus placebo and tiotropium. Least squares mean treatment difference between QVA149- placebo and QVA149- tiotropium were 1.92 (p0.001) and 0.76 (p=0.042) for SAC-TDI and 254mL and 92mL (both p0.001) for FEV1 AUC0-4h, respectively. CONCLUSIONS: In patients with severe COPD, once-daily QVA149 provided clinically meaningful and statistically superior improvements in lung function which translated into better control of breathlessness compared to placebo and standard tiotropium. CLINICAL IMPLICATIONS: Improved lung function with LABA/LAMA combination, QVA149, translates into greater relief of breathlessness and improved patient-reported outcomes. DISCLOSURE: Anthony D'Urzo: Consultant fee, speaker bureau, advisory committee, etc.: Novartis, AstraZeneca, Forest Laboratories, Pfizer, Schering Plough, Grant monies (from industry related sources): GSK, Schering Plough, Methapharma, AstraZeneca, Merck Canada, Forest Laboratories, Novartis Donald Mahler: Grant monies (from industry related sources): Boehringer Ingelheim, Novartis, and Sunovion, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Novartis, and Sunovion, and have served on Advisory Boards for Boehringer Ingelheim, GlaxoSmithKline, Novartis, Pearl, and Sunovion Tracy White: Employee: Novartis Pharmaceuticals Corporation Vijay Alagappan: Employee: Novartis Pharmaceuticals Corporation Hungta Chen: Employee: Novartis Pharmaceuticals Corporation Karoly Kulich: Employee: Novartis Pharma AG Nicola Gallagher: Employee: Novartis Horsham Research Centre Donald Banerji: Employee: Novartis Pharmaceuticals Corporation The following authors have nothing to disclose: Heinrich WorthClinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.