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

• Published in: BMC pulmonary medicine 2015-08, Vol.15 (1), p.91-91, Article 91
• Main Authors: Singh, Dave, Worsley, Sally, Zhu, Chang-Qing, Hardaker, Liz, Church, Alison
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adult; Bronchodilator Agents - administration & dosage; Comparative analysis; Double-Blind Method; Female; Fluticasone-Salmeterol Drug Combination - administration & dosage; Follow-Up Studies; Forced Expiratory Volume - drug effects; Humans; Male; Middle Aged; Patient compliance; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Quinuclidines - administration & dosage; Steroids; Treatment Outcome
• ISSN: 1471-2466; 1471-2466
• DOI: 10.1186/s12890-015-0092-1

Umeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta2 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. 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 (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, symptoms, quality of life (QoL) and safety. Improvements with UMEC/VI versus FP/SAL were 0.080 L (95 % confidence interval: 0.046-0.113; wmFEV1) and 0.090 L (0.055-0.125; trough FEV1) (both p