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AstraZeneca has confirmed that its triple combination therapy, Breztri Aerosphere, has met its primary endpoint in a Phase III clinical trial (ETHOS).
AstraZeneca has confirmed that its triple combination therapy, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6 µg), has met its primary endpoint in a Phase III clinical trial (ETHOS).
The Phase III trial assessed the efficacy and safety of Breztri Aerospherein patients with symptomatic chronic obstructive pulmonary disease (COPD) considered to be moderate to very severe. A primary endpoint of the trial was the rate of moderate or severe exacerbations, which was shown to be reduced at a statistically significant level by the medicine when compared with dual-combination therapies, according to the study’s results.
“Exacerbations are devastating events for patients and can lead to a permanent loss of lung function,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca? in an Aug. 28, 2019 press release. “The Phase III ETHOS trial builds on the Phase III KRONOS data which together show Breztri Aerosphere’sability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months. We look forward to sharing these results with health authorities as soon as possible.”
“The Phase III ETHOS trial results are exciting and demonstrate that Breztri Aerospheresignificantly reduces the rate of exacerbations,” added 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. “This is also the first time we have seen the benefit of fixed-dose triple-combination therapy at two inhaled corticosteroid doses, which could transform treatment practice by allowing physicians to select the optimal dose for individual patients.”
Additionally, AstraZeneca highlighted that a statistically significant reduction in exacerbations were also demonstrated with half the budesonide dose when compared with dual combination therapy. Full trial results are expected to be presented at an upcoming medical meeting.