Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial

BACKGROUND: Umeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta(2) agonist [LABA]) and the LABA/inhaled corticosteroid fluticasone propionate/salmeterol (FP/SAL) are approved maintenance treatments for chronic obstructive pulmonary disease (COPD). This 12-week, multicentre, double-blind, parallel-group, double-dummy study compared the efficacy and safety of these treatments in symptomatic patients with moderate-to-severe COPD with no exacerbations in the year prior to enrolment. METHODS: Patients (n = 717) were randomised 1:1 to once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 500/50 mcg. Endpoints included 0–24 h weighted mean (wm) forced expiratory volume in 1 s (FEV(1)) (Day 84; primary), trough FEV(1) (Day 85; secondary), other lung function endpoints, symptoms, quality of life (QoL) and safety. RESULTS: Improvements with UMEC/VI versus FP/SAL were 0.080 L (95 % confidence interval: 0.046–0.113; wmFEV(1)) and 0.090 L (0.055–0.125; trough FEV(1)) (both p < 0.001). UMEC/VI statistically significantly improved all other lung function measures versus FP/SAL. Both treatments demonstrated a clinically meaningful improvement in symptoms (Transition Dyspnoea Index ≥1 unit) and QoL (St George’s Respiratory Questionnaire Total score ≥4 unit decrease from baseline) over 12 weeks. The incidence of adverse events was 28 % (UMEC/VI) and 29 % (FP/SAL); nasopharyngitis and headache were most common. CONCLUSIONS: Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in significant and sustained improvements in lung function versus twice-daily FP/SAL 500/50 mcg in patients with moderate-to-severe COPD and with no exacerbations in the year prior to enrolment. TRIAL REGISTRATION: NCT01822899 Registration date: March 28, 2013 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12890-015-0092-1) contains supplementary material, which is available to authorized users.