Abstract
Background: In the Phase III, 52-week ETHOS study (NCT02465567), BGF MDI triple fixed-dose combination, reduced moderate/severe COPD exacerbation rate vs dual therapies; however, rates are known to vary by season.
Objective: To assess exacerbation rates by season in ETHOS.
Methods: Patients with moderate-to-very severe COPD and ≥1 moderate/severe exacerbation in the prior year received 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 twice-daily via a single Aerosphere inhaler. Annualised exacerbation rates were assessed using negative binomial regression.
Results: In the mITT population (n=8509), 56.5% of patients had ≥2 exacerbations in the previous year. BGF MDI 320/14.4/10 µg and 160/14.4/10 µg reduced exacerbation rate vs GFF MDI and BFF MDI (Figure); rate ratios vs GFF MDI for winter, spring, summer and fall were 0.83, 0.77, 0.71, 0.77 and 0.82, 0.82, 0.81, 0.66, respectively (all p<0.02 [unadjusted]); and vs BFF MDI were 0.88, 0.95, 0.80, 0.89 and 0.87, 1.01, 0.92, 0.77, respectively.
Conclusions: In patients with moderate-to-very severe COPD and an exacerbation history, seasonal variation in exacerbation rate occurred in each treatment group. A reduction in exacerbation rate was generally observed across all seasons for BGF MDI (both dose levels) vs LAMA/LABA and ICS/LABA.
Footnotes
Cite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 5238.
This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2020
