Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: The BRIGHT study

被引:89
作者
Beeh, Kai-Michael [1 ]
Korn, Stephanie [2 ]
Beier, Jutta [1 ]
Jadayel, Dalal [3 ]
Henley, Michelle [3 ]
D'Andrea, Peter [4 ]
Banerji, Donald [4 ]
机构
[1] Insaf Resp Res Inst, D-65187 Wiesbaden, Germany
[2] Mainz Univ Hosp, Dept Pulm, Mainz, Germany
[3] Novartis Horsham Res Ctr, Horsham, W Sussex, England
[4] Novartis Pharmaceut, E Hanover, NJ USA
关键词
Chronic obstructive pulmonary disease; QVA149; Exercise; Hyperinflation; Tiotropium; OBSTRUCTIVE PULMONARY-DISEASE; TWICE-DAILY SALMETEROL; ONCE-DAILY INDACATEROL; DAILY NVA237; DOUBLE-BLIND; TIOTROPIUM; HYPERINFLATION; EFFICACY; SAFETY; PLACEBO;
D O I
10.1016/j.rmed.2014.01.006
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
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 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 mu g, placebo or tiotropium 18 jig 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. (C) 2014 The Authors. Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码:584 / 592
页数:9
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