Umeclidinium/vilanterol in preventing clinically important deterioration (CID) in COPD and impact of baseline disease severity: the EMAX trial

Abstract

Background: The risk of short-term deterioration, assessed by the CID composite measure, is reduced with dual vs mono bronchodilators in inhaled corticosteroid (ICS)-free symptomatic patients with COPD. It is unclear if this protection alters with baseline severity of COPD. Aims: This pre-specified secondary analysis of the Early MAXimization of bronchodilation for improving COPD stability (EMAX) trial compared CID risk in the ITT population and in severity subgroups with a baseline GOLD spirometric grade 3 (FEV1 30–50% predicted) or COPD Assessment Test (CAT) score ≥20. Methods: This 24-week, double-blind, parallel-group trial randomised patients to umeclidinium/vilanterol (UMEC/VI) 62.5/25 µg QD, UMEC 62.5 µg QD, or salmeterol (SAL) 50 µg BID. Risk of a first CID was assessed using 3 definitions of CID (Figure). Results: In the ITT population and subgroups, CID risk was lower with UMEC/VI vs UMEC or SAL for all CID definitions, except in one instance (Figure). This protection was numerically higher in the GOLD 3 subgroup regardless of CID definition, but not in the CAT ≥20 subgroup. Conclusions: In symptomatic ICS-free patients at low exacerbation risk, UMEC/VI reduced CID risk vs UMEC and SAL. Compared with the ITT population, this protection was greater in patients with more severe airflow limitation but not with more symptoms. Funding: GSK (study 201749; NCT03034915)