Abstract
Introduction
The QUANTIFY study compared QVA149, an approved once-daily (OD) LABA (indacaterol) plus LAMA (glycopyrronium) dual bronchodilator combination, with the free-dose combination of tiotropium plus formoterol (TIO+FOR) regarding lung function, dyspnoea and health-related quality of life in patients with COPD.
Methods
This double-blind, triple-dummy 26-week study randomised patients with moderate-to-severe COPD to QVA149 110/50µg OD or TIO 18µg OD plus FOR 12µg b.i.d. (1:1). Endpoints included pre-dose FEV1 and FVC, TDI responder rates and St George's Respiratory Questionnaire-COPD (SGRQ-C).
Results
Of the 934 patients randomised (QVA149 [N=476] and TIO+FOR [N=458]) 87.9% completed the study. Non-inferiority of QVA149 was met with respect to SGRQ-C (least square mean treatment difference [LSMTD] –0.69 units, 95% CI –2.31 to 0.92). QVA149 showed statistically significant improvements in lung function (pre-dose FEV1: LSMTD=68 mL, p<0.001; pre-dose FVC: LSMTD=74 mL, p<0.01) and TDI responder rates (risk ratio=1.17; p<0.05) versus TIO+FOR. Similarly, QVA149 significantly improved pre-dose FEV1 irrespective of age, gender, inhaled corticosteroid (ICS) use and COPD severity (Figure 1).
Conclusion
QVA149 significantly improved lung function as well as dyspnoea and was non-inferior in improving health-related quality of life compared with TIO+FOR free-dose combination.
- © 2014 ERS