Abstract
Introduction
QVA149 is a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) for the treatment of COPD. This study evaluated the safety and efficacy of once-daily QVA149 vs. the free combination of IND+GLY.
Methods
In this multicenter, double-blind, parallel group, non-inferiority study, patients with moderate-to-severe COPD were randomized (1:1) to QVA149 (110/50µg) plus placebo or IND (150µg) plus GLY (50µg) via the Breezhaler® device for 4wks. 184 randomized patients were planned to give the study 90% power to rule out that forced expiratory volume in 1 second (FEV1) for QVA149 being 100mL worse than the concurrent administration of IND and GLY. Here we present the lung function results after 4wks.
Results
Of the 193 patients randomized (QVA149 [n=90], IND+GLY [n=103]); mean age: 64.9yrs; mean post-bronchodilator FEV1: 54.0%, FEV1/forced vital capacity (FVC): 46.0% predicted; 181 patients were analyzed and 96.9% completed. At Wk4, QVA149 showed similar improvement in trough FEV1 as compared to IND+GLY (least squares mean [LSM] treatment [Tx] difference 5.0mL; 95% confidence interval [CI]: –51, 40). The LSM-Tx difference of FEV1 area under curve (AUC0–4h) for QVA149 vs. IND+GLY at Wk 4 was 12mL; 95% CI: –59, 34. Overall, safety profile was also similar for both groups.
Conclusion
Once-daily QVA149 offers the convenience of two bronchodilators in a single device while providing the same improvement in lung function compared to the co-administration of its monocomponents.
- © 2013 ERS