AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) significantly cut 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).
According to data from the Phase III Ethos trial, published in the New England Journal of Medicine, when compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) Breztri Aerosphere achieved reduction in exacerbations of 24% and 13%, respectively.
Also, in a key secondary endpoint, the triple therapy showed a 46% reduction in the risk of all-cause mortality compared with Bevespi Aerosphere.
“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D. “We are excited to have the data on all-cause mortality, which is a key consideration for COPD management.”
According to AZ, Breztri Aerosphere's safety and tolerability were consistent with the known profiles of the dual comparators.
The most frequently reported adverse events in the trial were nasopharyngitis, COPD and upper respiratory tract infection. The incidence of confirmed pneumonia was 4.2% with Breztri Aerosphere, 2.3% with Bevespi Aerosphere and 4.5% with PT009.
Breztri Aerosphere is approved in Japan and China for patients with COPD, and is under regulatory review in the US and EU.