P190 QVA149 Once Daily Provides Significant Improvements in Lung Function Over 1 Year in Patients with COPD: The Enlighten Study: Abstract P190 Table 1

Abstract

Introduction QVA149 is a novel inhaled once-daily dual bronchodilator, containing a fixed-dose combination of the long-acting (beta)2-agonist indacaterol and the long-acting muscarinic antagonist NVA237 (glycopyrronium) in development for the treatment of COPD. This study evaluated the long-term effect of QVA149 on lung function in patients with COPD. Methods This was a multicentre, double-blind, parallel group, placebo-controlled study in which patients with moderate-to-severe COPD were randomised (2:1) to receive QVA149 (110/50(mu)g) or placebo once daily via the Breezhaler(registered trademark) device for 52 weeks. Treatment was taken in the morning at the same time of day. Lung function was measured as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) at 30 and 60 minutes post-dose at clinic visits over 52 weeks. Results 339 patients (77% male, mean age 63 years; mean post-salbutamol FEV1 57% predicted, FEV1/FVC 54%) were randomised to receive QVA149 (n=226) or placebo (n=113); 86% and 79% of patients respectively completed treatment, respectively. QVA149 significantly increased FEV1 and FVC versus placebo at all assessment points Conclusion QVA149 once daily provided rapid and clinically meaningful bronchodilation compared with placebo. No tachyphylaxis was observed and the bronchodilator effect was sustained over the 52 week treatment period. (Table presented).