Abstract
Introduction
Once-daily (OD) QVA149 offers the convenience of two bronchodilators in a single device. This study compared QVA149 to the co-administration of its monocomponents, the long-acting β2-agonist (LABA) indacaterol (IND) and long-acting muscarinic antagonist (LAMA) glycopyrronium (GLY).
Methods
In this multicenter, double-blind, parallel group study, patients with moderate-to-severe COPD were randomized (1:1) to OD QVA149 (110/50µg) or IND (150µg)+GLY (50µg) via the Breezhaler® device for 4wks. Here we present safety results after 4wks.
Results
193 patients were randomized, mean age: 64.9yrs, 96.9% completed. Daily rescue medication use was reduced by –0.42 and –0.49 puffs/day for QVA149 and IND+GLY, respectively over 4wks. Incidence of adverse events (AEs) was similar in both groups over 4wks (Table). Similar frequency of serious AEs was seen for QVA149 (4.4%) and IND+GLY (5.8%); no deaths were reported in either group. No clinically meaningful change in laboratory results, vital signs or ECGs in any group was observed.
Conclusion
The safety and tolerability of once-daily QVA149 was similar to the free combination of its monocomponents IND and GLY.
- © 2013 ERS