COPD exacerbation rates by month in the ETHOS trial with budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) at two ICS dose levels

Abstract

Background: In the 52-week ETHOS trial (NCT02465567), the triple fixed-dose combination BGF MDI containing 320 µg or 160 µg budesonide reduced the rate of moderate/severe COPD exacerbations vs dual therapies. Objective: To assess exacerbation rates by month of treatment in the ETHOS trial. Methods: Patients with moderate-to-very severe COPD and ≥1 moderate/severe exacerbation in the prior year were randomised to BGF MDI 320/14.4/10 µg or 160/14.4/10 µg, glycopyrronium/formoterol (GFF) MDI 14.4/10 µg or budesonide/formoterol (BFF) MDI 320/10 µg, each administered twice-daily via a single Aerosphere inhaler. In a pre-specified analysis, annualised exacerbation rates were assessed in consecutive 4-week intervals using generalised estimating equation modelling. Results: In the modified ITT population (n=8509), 56.5% had experienced ≥2 moderate/severe exacerbations in the previous year; 80.5% were using ICS at screening. Within each treatment group, exacerbation rates by monthly interval were generally consistent across the study period. The rate ratios were Conclusions: Reductions in COPD exacerbation rates with BGF MDI 320/14.4/10 µg (ICS/LAMA/LABA) vs LAMA/LABA were observed throughout the study and not only during the early weeks of treatment.