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


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 (FEV1) (Day 84; primary), trough FEV1 (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; wmFEV1) and 0.090 L (0.055-0.125; trough FEV1) (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.


BACKGROUND
NCT01822899 Registration date: March 28, 2013.
University of Manchester, Medicines Evaluation Unit, Langley Building, University Hospital of South Manchester Foundations Trust, Southmoor Road, Manchester, M23 9QZ, UK. dsingh@meu.org.uk.
Dave
D
Singh
Respiratory Medicines Development Centre, GSK, London, UK. sally.d.worsley@gsk.com.
Sally
S
Worsley
Quantitative Sciences Division, GSK, London, UK. chang-qing.2.zhu@gsk.com.
Chang-Qing
CQ
Zhu
Global Clinical Safety and Pharmacovigilance, GSK, London, UK. liz.x.hardaker@gsk.com.
Liz
L
Hardaker
Respiratory Medicines Development Center, GSK, Research Triangle Park, North Carolina, USA. alison.x.church@gsk.com.
Alison
A
Church
D000280:Administration, Inhalation; D000328:Adult; D001993:Bronchodilator Agents / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D011812:Quinuclidines / Q000008:administration & dosage*; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination; C573971:GSK573719; D011812:Quinuclidines