Abstract
We evaluated the effect of QVA149, a dual bronchodilator combining indacaterol and glycopyrronium, on direct patient-reported dyspnoea in patients with moderate-to-severe COPD.
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 (BDI/TDI) after 6 weeks. Secondary endpoints included lung function, rescue medication use and safety.
After 6 weeks, the SAC TDI 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 FEV1 area under the curve from 0 to 4 hours 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