P191 QVA149 once daily improves exercise tolerance and lung function in patients with moderate to severe COPD: the BRIGHT study: Abstract P191 Table 1

Abstract

Poster sessionsThorax 2012;67(Suppl 2):A1-A204 A147 completed the study. At Day 21, QVA149 significantly improved exercise endurance time by 59.5 seconds versus placebo (p=0.006), which was of a similar magnitude to the improvement seen with tiotropium versus placebo (66.3 seconds; p=0.002). More patients stopped exercise due to dyspnoea with placebo (43% versus 36% with both QVA149 and tiotropium) and due to muscle fatigue with QVA149 and tiotropium (44-46% versus 38% with placebo). QVA149 also produced significant and clinically meaningful improvements in trough FEV 1 , dynamic IC at exercise isotime, trough IC and trough FVC versus placebo and tiotropium ( Introduction QVA149 is a novel inhaled once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist NVA237 (glycopyrronium) in development for the maintenance treatment of COPD. This study evaluated the effect of QVA149 on P192Michael 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. Introduction QVA149 is a novel once-daily fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237) in development for the treatment of chronic obstructive pulmonary disease (COPD). The BRIGHT study evaluated the effects of QVA149 versus placebo and tiotropium on exercise tolerance and lung function in patients with moderate-to-severe COPD. Methods In a double-blind, double-dummy, 3-period crossover study, patients with moderate-to-severe COPD were randomised to QVA149 110/50 µg, placebo or tiotropium 18 µg once daily for 3 weeks. The primary endpoint was exercise endurance time for QVA149 versus placebo during a submaximal exercise tolerance test (SMETT) via cycle ergometry at Day 21. Dynamic inspiratory capacity (IC) at isotime during exercise, trough IC, trough FEV 1 and trough forced vital capacity (FVC) were also measured. Results Eighty five patients were randomised; mean age was 62 years, mean post-bronchodilator FEV 1 56% predicted. 86% patients QVA149 ONCE DAILY IMPROVES EXERCISE TOLERANCE AND LUNG FUNCTION IN PATIENTS WITH MODERATE TO SEVERE COPD: THE BRIGHT STUDY

Physical activity in COPD patients decreases short-acting bronchodilator use and the number of exacerbations

“…This observation is consistent with our earlier finding that disregarding the disease stage in inactive patients who suffered more from the sensitization of dyspnoea than active patients [11]. Maximal bronchodilation improves COPD patients' physical performance, for example by decreasing dynamic hyperinflation [27,28]. We found no evidence that physical activity would associate with the use of long-acting bronchodilators in this reallife COPD cohort.…”

New combination bronchodilators for chronic obstructive pulmonary disease: current evidence and future perspectives

“…Bronchodilators decrease hyperinflation, and perhaps patients with more hyperinflation will be responders to LABA/LAMA FDCs. BRIGHT showed superiority for QVA149 over tiotropium on resting and dynamic hyperinflation . Disappointingly, these physiological advantages for QVA149 did not translate into improved exercise endurance compared with tiotropium.…”

Profile of inhaled glycopyrronium bromide as monotherapy and in fixed-dose combination with indacaterol maleate for the treatment of COPD

“…BRIGHT was a 3-week, randomized trial that evaluated QVA149 versus placebo and tiotropium on exercise tolerance, hyperinflation, lung function, and volumes in patients with moderate to severe COPD. 35 At day 21, QVA149 significantly improved inspiratory capacity during exercise (at isotime), compared with both placebo (Δ=0.32 L, P <0.001) and tiotropium (Δ=0.13 L, P <0.01), and with significant improvements in trough inspiratory capacity of 0.19 L ( P <0.01) and 0.14 L ( P <0.01), respectively. QVA149 improved exercise endurance time (by 59.5 seconds) compared with placebo ( P =0.006) but not compared with tiotropium.…”

“…The principal investigations of efficacy were the 26-week ILLUMINATE 31 and SHINE trials, 32 primarily focusing on lung function, and the 64-week SPARK 33 trial that assessed efficacy with respect to exacerbation frequency. Dyspnea and exercise tolerance were assessed in the 3-week BLAZE 34 and 6-week BRIGHT 35 trials, respectively. ENLIGHTEN 36 was a 52-week safety trial, and the BEACON 37 trial was a noninferiority study of bronchodilation at 4 weeks compared with coadministration of the monocomponents.…”