ETHOS
Budesonide/Glycopyrrolate/Formoterol Triple Therapy in COPD
Patient / Population Intervention / Exposure Comparison Outcome
In 8,509 patients with moderate-to-very-severe COPD, budesonide/glycopyrrolate/formoterol (BGF 320/18/9.6 µg) reduced annual exacerbations compared with LAMA/LABA (GFF) and LABA/ICS (BFF).
N
8,509
Design
Multicentre RCT, 4-arm
Endpoint
Annual rate of moderate or severe exacerbations
Relevance
2
ResultBGF 320 vs GFF: RR 0.76 (95% CI 0.69–0.83); vs BFF: RR 0.87 (0.79–0.95). All-cause mortality BGF 320 vs GFF HR 0.54 (0.34–0.87).
Rabe KF, et al. N Engl J Med. 2020;383(1):35-48. 10.1056/NEJMoa1916046
Discussion & critique
Corroborates IMPACT mortality signal but shares the same ICS-withdrawal asymmetry critique.