A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

Summary

To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients

Timeline

Start

2013-03-23

Primary completion

2018-06-04

Completion

2018-06-04

Outcome

Met primary endpoint

registry analysis (superiority test); Indacaterol and Glycopyrronium (QVA149) vs Tiotropium; p = 0.0129; Mean Difference (Net) 0.05 (95% CI 0.011 to 0.093); ANCOVA NCT02566031 ↗

Publications

• Rhee CK, Park HY, Park JW, Lee JH, Kim TH, Lee SW, Jung JY, Kim S, Hwang YI, Jung KS. Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial. Trials. 2017 Feb 22;18(1):80. doi: 10.1186/s13063-017-1800-3.

Drugs

Indications