AstraZeneca has reported that its combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) has decreased the rate of moderate or severe exacerbations caused by chronic obstructive pulmonary disease (COPD).
The findings are from the Phase III ETHOS clinical trial conducted in patients with moderate to very severe COPD. The study compared the triple combination therapy to Bevespi Aerosphere (glycopyrronium/formoterol fumarate).
Data showed a 24% reduction with Breztri Aerosphere when compared to Bevespi Aerosphere. In addition, the triple combination demonstrated a 13% decrease versus PT009 (budesonide/formoterol fumarate).
The company added that Breztri Aerosphere led to a 46% reduction in the risk of all-cause mortality, a key secondary endpoint, compared to Bevespi Aerosphere.
ETHOS is a randomised, double-blinded, multi-centre, parallel-group, 52-week study intended to evaluate the safety and efficacy of Breztri Aerosphere in more than 8,500 symptomatic patients.
In the trial, the safety and tolerability of Breztri Aerosphere were found to be consistent with the known profiles of the comparators. The most frequent adverse events were nasopharyngitis, COPD and upper respiratory tract infection.
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AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos 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.”
Breztri Aerosphere has approvals in Japan and China to treat patients with COPD and is under regulatory review in the US and EU.
The ETHOS trial is part of AstraZeneca’s ATHENA Phase III clinical programme for Breztri Aerosphere, which included more than 15,500 patients across 11 trials worldwide.