Kai-Michael Beeh1, Stephanie Korn2, Jutta Beier3, Dalal Jadayel4, Michelle Henley4, Peter D'Andrea5, Donald Banerji5. 1. insaf Respiratory Research Institute, Wiesbaden, Germany. Electronic address: k.beeh@insaf-wi.de. 2. Pulmonary Department, Mainz University Hospital, Mainz, Germany. 3. insaf Respiratory Research Institute, Wiesbaden, Germany. 4. Novartis Horsham Research Center, Horsham, UK. 5. Novartis 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 glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the effects of QVA149 on exercise tolerance, hyperinflation, lung function and lung volumes versus placebo and tiotropium. METHODS:Patients with moderate-to-severe COPD were randomized to QVA149 110/50 μg, placebo or tiotropium 18 μg once daily in a blinded, 3-period crossover study for 3 weeks. The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo. RESULTS:Eighty-five patients were randomized; 86% completed the study. QVA149 significantly improved exercise endurance time at Day 21 compared with placebo (least squares mean treatment difference 60 s [p = 0.006]). No significant improvements in exercise endurance time at Day 21 between QVA149 and tiotropium were found. Dynamic inspiratory capacity (IC) at exercise isotime, trough forced expiratory volume in 1 s, residual volume and functional residual capacity showed significant improvements with QVA149 from Day 1 of treatment that were maintained throughout the study. The safety profiles were similar across groups. CONCLUSIONS: In patients with moderate-to-severe COPD, once-daily QVA149 significantly improved exercise endurance time compared with placebo which was associated with sustained reductions of lung hyperinflation as indicated by significant improvement in IC at rest and during exercise. TRIAL REGISTRATION: ClinicalTrials.gov NCT01294787. TAKE HOME MESSAGE: Dual bronchodilation with QVA149 decreases lung hyperinflation and improves exercise tolerance and lung function in patients with moderate-to-severe COPD.
RCT Entities:
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 glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the effects of QVA149 on exercise tolerance, hyperinflation, lung function and lung volumes versus placebo and tiotropium. METHODS:Patients with moderate-to-severe COPD were randomized to QVA149 110/50 μg, placebo or tiotropium 18 μg once daily in a blinded, 3-period crossover study for 3 weeks. The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo. RESULTS: Eighty-five patients were randomized; 86% completed the study. QVA149 significantly improved exercise endurance time at Day 21 compared with placebo (least squares mean treatment difference 60 s [p = 0.006]). No significant improvements in exercise endurance time at Day 21 between QVA149 and tiotropium were found. Dynamic inspiratory capacity (IC) at exercise isotime, trough forced expiratory volume in 1 s, residual volume and functional residual capacity showed significant improvements with QVA149 from Day 1 of treatment that were maintained throughout the study. The safety profiles were similar across groups. CONCLUSIONS: In patients with moderate-to-severe COPD, once-daily QVA149 significantly improved exercise endurance time compared with placebo which was associated with sustained reductions of lung hyperinflation as indicated by significant improvement in IC at rest and during exercise. TRIAL REGISTRATION: ClinicalTrials.gov NCT01294787. TAKE HOME MESSAGE: Dual bronchodilation with QVA149 decreases lung hyperinflation and improves exercise tolerance and lung function in patients with moderate-to-severe COPD.
Authors: Gary T Ferguson; Matjaž Fležar; Stephanie Korn; Lawrence Korducki; Lars Grönke; Roger Abrahams; Roland Buhl Journal: Adv Ther Date: 2015-06-26 Impact factor: 3.845
Authors: Kai M Beeh; Henrik Watz; Luis Puente-Maestu; Luis de Teresa; Diana Jarreta; Cynthia Caracta; Esther Garcia Gil; Helgo Magnussen Journal: BMC Pulm Med Date: 2014-12-23 Impact factor: 3.317