Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Breztri Aerosphere achieved a 24% reduction (p<0.001) in exacerbations. Breztri Aerosphere achieved a 13% reduction (p=0.003) compared with PT009 (budesonide/formoterol fumarate). The dual-combination therapies used as comparators in the trial represent recommended therapeutic classes for the treatment of COPD.2
In a key secondary endpoint, Breztri Aerosphere showed a 46% reduction in the risk of all-cause mortality compared with Bevespi Aerosphere (unadjusted p=0.01).3
The results were published in the New England Journal of Medicine. AstraZeneca will continue to review these data with health authorities.
“Chronic obstructive pulmonary disease is the third leading cause of death worldwide and exacerbations can contribute to an increase in mortality in these patients. The results of the Phase III ETHOS trial support the strong clinical profile of Breztri Aerosphere in reducing exacerbation rates compared with dual-combination therapies. We are excited to have the data on all-cause mortality, which is a key consideration for COPD management,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
Breztri Aerosphere is approved in Japan and China for patients with COPD. It is under regulatory review in the US and EU.