P247 Umeclidinium/vilanterol (UMEC/VI) versus mono-bronchodilator therapy in steroid-free GOLD B patients with chronic obstructive pulmonary disease (COPD): the EMAX trial
Abstract
Introduction Long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combination therapy is more effective than monotherapies for improving lung function, breathlessness and health status, in patients with moderate-to-severe COPD (Oba et al. Thorax 2016:71;15–25). Current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy highlights that first-line maintenance therapy in symptomatic GOLD B patients is LAMA or LABA monotherapy (GOLD 2018 report). The Early MAXimal bronchodilation for improving COPD stability (EMAX) trial aims to compare the efficacy and safety of UMEC/VI (LAMA/LABA), UMEC (LAMA) and salmeterol (SAL [LABA]) in symptomatic, steroid-free GOLD B patients with COPD (study 201749; NCT03034915) to inform the positioning of dual versus monotherapy within treatment guidelines for GOLD B patients. Methods EMAX is a 24 week, multicentre, double-blind, double-dummy, parallel-group study. Patients (n=2,431) were randomised 1:1:1 to UMEC/VI 62.5/25 mcg, UMEC 62.5 mcg or SAL 50 mcg (figure 1). Patients were required to be aged ≥40 years, current/former smokers (≥10 pack-years), with a forced expiratory volume in 1 s (FEV1)/forced vital capacity ratio <0.70, post-salbutamol FEV1 ≥30% to≤80% predicted, COPD Assessment Test (CAT) score ≥10, and ≤1 moderate and no severe exacerbations in the past year. Randomisation was stratified by maintenance bronchodilator use (none or one permitted) at screening. The primary endpoint is trough FEV1 with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,431 participants or records.
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