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Randomized Controlled Trial Multicenter Study
Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study.
- Donald A Mahler, Marc Decramer, Anthony D'Urzo, Heinrich Worth, Tracy White, Vijay K T Alagappan, Hungta Chen, Nicola Gallagher, Károly Kulich, and Donald Banerji.
- Section of Pulmonary and Critical Care Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH, USA Donald.A.Mahler@hitchcock.org.
- Eur. Respir. J. 2014 Jun 1;43(6):1599-609.
AbstractWe evaluated the effect of QVA149, a dual bronchodilator combining indacaterol and glycopyrronium, on direct patient-reported dyspnoea in patients with moderate-to-severe chronic obstructive pulmonary disease. In this multicentre, blinded, double-dummy, three-period crossover study, 247 patients were randomised to once-daily QVA149 110/50 μg, placebo or tiotropium 18 μg. Superiority of QVA149 versus placebo (primary objective) and tiotropium (secondary objective) was assessed for improvement in dyspnoea via the self-administered computerised (SAC) version of the Baseline and Transition Dyspnoea Index after 6 weeks. Secondary end-points included lung function, rescue medication use and safety. After 6 weeks, the SAC Transition Dyspnoea Index total score was significantly higher with QVA149 versus placebo (least squares mean (LSM) treatment difference 1.37, p<0.001) and tiotropium (LSM treatment difference 0.49, p=0.021). QVA149 provided significant improvements in lung function, with higher forced expiratory volume in 1 s area under the curve from 0-4 h post-dose versus placebo and tiotropium at day 1 and week 6 (all p<0.001). Rescue medication use was significantly lower with QVA149 versus placebo (p<0.001) and tiotropium (p=0.002). All treatments were well tolerated. Once-daily QVA149 provided superior improvements in patient-reported dyspnoea and lung function versus placebo and tiotropium. These benefits were associated with improvements in other symptoms and reduced use of rescue medication.©ERS 2014.
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