June 24, 2020: “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).
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.
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).
The results were published in the New England Journal of Medicine and simultaneously presented at the American Thoracic Society virtual Scientific Symposium, Clinical Trial Results in Pulmonary Medicine.3 AstraZeneca will continue to review these data with health authorities.
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, said: “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. 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, said: “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.”
The safety and tolerability of Breztri Aerosphere were consistent with the known profiles of the dual comparators.
In the trial, the most frequently reported adverse events 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.
These results are based on Breztri Aerosphere at the standard dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg), an inhaled corticosteroid (ICS). In the trial, Breztri Aerosphere at half the dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 160/14.4/9.6mcg) also demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg).
Breztri Aerosphere is approved in Japan and China for patients with COPD. It is under regulatory review in the US and EU.”
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/breztri-aerosphere-significantly-reduced-rate-of-moderate-or-severe-copd-exacerbations-in-phase-iii-ethos-trial.html
