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Severe lung disease progression and transplantation
P190 QVA149 Once Daily Provides Significant Improvements in Lung Function Over 1 Year in Patients with COPD: The Enlighten Study
  1. R Dahl1,
  2. K Chapman2,
  3. M Rudolf3,
  4. R Mehta4,
  5. P Kho5,
  6. V Alagappan6,
  7. I Berhane6,
  8. H Chen6,
  9. D Banerji6
  1. 1Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark
  2. 2Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Toronto, Canada
  3. 3Department of Respiratory Medicine, Ealing Hospital NHS Trust and Imperial College, London, UK
  4. 4Allergy and Asthma Care, Allergy and Asthma Care and Research Centre, Indore, India
  5. 5Novartis Horsham Research Center, Horsham, West Sussex, UK
  6. 6Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

Abstract

Introduction QVA149 is a novel inhaled once-daily dual bronchodilator, containing a fixed-dose combination of the long-acting β2-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 (110/50µg) or placebo once daily via the Breezhaler® 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 (table).

Abstract P190 Table 1

QVA149 versus placebo least squares mean (LSM) differences in FEV1 and FVC

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.

Ronal Dahl: he participated in advisory boards for Novartis, AstraZeneca, Boehringer-Ingelheim, Pfizer, ALK-Abello, UCB, Nycomed, Dainippon and ONO.

Kenneth R Chapman: he holds the GSK-CIHR Research Chair in Respiratory Healthcare Delivery at the University Health Network, has served as a consultant to CSL Behring, GlaxoSmithKline, Novartis, Nycomed (Takeda), and Talecris (Grifols), and has received payment for lectures or service on speakers bureaus from Boehringer-Ingelheim, GlaxoSmithKline, Grifols, Nycomed (Takeda), Family Physicians Airways Group of Canada, Canadian Network for Respiratory Care, and Talecris.

Michael Rudolf: he has been reimbursed by the following companies for speaking at educational meetings, for consultancy work, or for attending scientific conferences: Almirall, Astra-Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck Sharp and Dohme, Napp, Novartis, Pfizer, Schering-Plough, and Teva.

Rajendra Mehta: he has no conflicts of interest.

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