Abstract
Introduction
Once-daily (OD) QVA149 is a dual bronchodilator combining the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium. The ARISE study evaluated the long-term safety and efficacy of QVA149 in Japanese patients (pts) with moderate-to-severe COPD.
Methods
This 52wk study randomized pts to OD QVA149 110/50μg (via the Breezhaler® device) or open-label tiotropium (TIO) 18μg OD (via the Handihaler® device). Here we present the efficacy evaluating forced expiratory volume in one second (FEV1), health status via the St. George’s Respiratory Questionnaire (SGRQ) score and rescue medication use. Safety and tolerability were also assessed.
Results
160 pts were randomized, 88.8% completed. Lung function, rescue medication use and SGRQ changes are in table. Majority of AEs were mild to moderate in severity. Incidence rate of AEs was 84.0% for QVA149 and 71.8% for TIO. AEs with >10% incidence in any group were nasopharyngitis (33.6 and 30.8%) and COPD worsening (26.9 and 20.5%) for QVA149 and TIO, respectively.
Conclusions
QVA149 improved lung function, health status and was safe and well tolerated in Japanese patients with COPD.
- © 2013 ERS