Real-world effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol in Chinese patients with symptomatic chronic obstructive pulmonary disease (COPD): a post-marketing, prospective, multicenter, observational study.

Abstract

Objective: To assess the effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) in symptomatic chronic obstructive pulmonary disease (COPD) under real-world settings in China.

Methods: In this single-arm, prospective, observational study, participants received 12 weeks of FF/UMEC/VI treatment. The primary outcome was change from baseline (CFB) in COPD Assessment Test (CAT) score at Week 12. Secondary outcomes included CFB in modified Medical Research Council (mMRC) dyspnea scale score and pre-dose forced expiratory volume in one second (FEV₁), and proportion of CAT responders at Week 12.

Results: From 14 October 2022 to 25 June 2023, 460 participants were enrolled; 392 (85.2%) completed the study treatment. After a 12-week treatment, there was a clinically meaningful CFB in CAT score with a mean of -6.81 (95% CI = -7.28-6.33); the proportion of CAT responders (≥2 points reduction from baseline) was 86%; the mean CFB in mMRC score was -0.52 (95% CI = -0.60∼-0.43); and pre-dose FEV₁ showed a clinically meaningful improvement from baseline with a mean of 0.13 L (95% CI = 0.10 ∼ 0.16). During the treatment, 10 (2.2%) participants reported FF/UMEC/VI-related adverse events.

Conclusion: In real-world clinical practice in China, FF/UMEC/VI effectively improved symptoms and lung function in patients with symptomatic COPD and was well-tolerated.