Phase III Trial Results Demonstrate Benefit of AstraZeneca’s Breztri Aerosphere

According to a June 24, 2020 press release, full results from the Phase III ETHOS trial have demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) after treatment with triple-combination therapy Breztri Aerosphere.

The study, results of which have been published in the New England Journal of Medicine, compared the efficacy and safety of triple combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) with the dual combination therapies, Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). Through the direct comparison, study investigators found that Breztri Aerosphere achieved a 24% reduction in exacerbations versus Bevespi Aerosphere, and a 13% reduction in exacerbations versus PT009. Additionally, the triple combination therapy demonstrated a 46% reduction in the risk of all-cause mortality compared with Bevespi Aerosphere.

“The Phase III ETHOS trial results are important and demonstrate the benefit of Breztri Aerosphere in reducing the rate of exacerbations in this progressive disease,” said Klaus Rabe, professor of Pulmonary Medicine at the University of Kiel, director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and lead investigator of the ETHOS trial, in the press release. “The findings also show that reducing risk of all-cause mortality is achievable and could transform treatment goals in chronic obstructive pulmonary disease.” 

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, added, in the press release, “COPD 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.”

Breztri Aerosphere is under regulatory review in the United States and the European Union. It is already approved for use in Japan and China for patients with COPD.

Source: AstraZeneca