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

Dave Singh,Sally Worsley,Chang-Qing Zhu,Liz Hardaker,Alison Church

doi:10.1186/s12890-015-0092-1

Abstract

BackgroundUmeclidinium (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.MethodsPatients (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.ResultsImprovements 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.ConclusionsOnce-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 RegistrationNCT01822899 Registration date: March 28, 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-015-0092-1) contains supplementary material, which is available to authorized users.

Highlights

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)
Patient demographics and characteristics were similar between groups (Table 1) and 55 % and 45 % of patients overall were categorised as Global Initiative for Chronic Obstructive Lung DiseaseTM (GOLD) B and D, respectively
The increased effect of UMEC/VI compared with FP/SAL was demonstrated in the 0–24 h serial forced expiratory volume in 1 s (FEV1) measurements on Day 84 (Fig. 2)

Summary

Introduction

Umeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta 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. Inhaled corticosteroids (ICS) are used to reduce exacerbations in patients with COPD with moderate-to-very severe airflow limitation, and there is good evidence for the efficacy of combination ICS/long-acting beta agonist (LABA) treatments in patients with a history of exacerbations (i.e., GOLD C and D patients) [1]. An important clinical question is how the efficacy of UMEC/VI compares with that of ICS/LABA combinations, which are often used in symptomatic patients with COPD who do not have a history of exacerbations (i.e., GOLD B and a subset of GOLD D patients)

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