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

Autor: Paul Dorinsky, Roopa Trivedi, Patrick Darken, Jadwiga A. Wedzicha, Earl St Rose, Colin Reisner, Chen Wang, Magnus Aurivillius, Shaila Ballal, Dave Singh, Klaus F. Rabe, Gary T. Ferguson, J. McLaren, Fernando J. Martinez
Rok vydání: 2020
Předmět:
Zdroj: Airway pharmacology and treatment.
DOI: 10.1183/13993003.congress-2020.977
Popis: 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.
Databáze: OpenAIRE