QVA149 once-daily is safe and well tolerated and improves lung function and health status in Japanese patients with COPD: The ARISE study

TLDR: QVA149 improved lung function, health status and was safe and well tolerated in Japanese patients with COPD, evaluated in the ARISE study.

Abstract: Introduction Once-daily (OD) QVA149 is a dual bronchodilator combining the long-acting β 2 -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 (FEV 1 ), 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.