Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) outperformed Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in reducing the rate of moderate or severe exacerbations in people with chronic obstructive pulmonary disease (COPD) during all seasons of the year, new data from the ETHOS clinical trial show.
That data will be presented by AstraZeneca — the developer of both Breztri Aerosphere and Bevespi Aerosphere — at the European Respiratory Society (ERS) International Virtual Congress 2020, held online Sept. 7-9, according to a company press release.
A triple combination therapy, Breztri Aerosphere contains the corticosteroid budesonide, as well as two types of bronchodilators: glycopyrronium and formoterol fumarate. Bronchodilators are medicines that open up or dilate the breathing passages by relaxing the bronchial smooth muscle. The therapy is designed to reduce the frequency of COPD exacerbations — episodes in which the disease’s symptoms suddenly get worse — and to ease associated symptoms.
The Phase 3 ETHOS clinical trial (NCT02465567) tested the safety and efficacy of Breztri Aerosphere compared with Bevespi Aerosphere and Symbicort (budesonide-formoterol fumarate) — another therapy developed by AstraZeneca — in people with moderate-to-very-severe COPD.
Previous results from the trial showed that Breztri Aerosphere significantly lowered the frequency of exacerbations compared with the other therapies at the highest tested dose. Specifically, exacerbations were reduced by 24% compared with Bevespi Aerosphere, and by 13% compared with Symbicort.
Based on these results, the U.S. Food and Drug Administration (FDA) approved Breztri Aerosphere as a maintenance COPD treatment earlier this year. The therapy also has been approved for COPD treatment in China and Japan.
The presentation at ERS 2020 is titled “Seasonal variation in COPD exacerbation rates: budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) at two ICS dose levels in the ETHOS trial.” It includes data from a post-hoc analysis of the ETHOS trial results — that is, an analysis done after the trial was already completed.
This analysis assessed the efficacy of the medications based on the season of the year, which can substantially impact people with COPD.
“Treating patients with chronic obstructive pulmonary disease can be challenging in the winter as they experience more frequent and more severe exacerbations, contributing to increased morbidity and mortality,” Gary Ferguson, MD, clinical professor of medicine at Michigan State University and investigator in the ETHOS trial, said in the press release.
The results showed that Breztri Aerosphere reduced the rate of COPD exacerbations across all seasons compared with Bevespi Aerosphere.
“These additional data from the Phase 3 ETHOS trial are important in supporting clinicians’ understanding of the robust clinical profile of Breztri Aerosphere, which has been approved in the US, China and Japan and is under regulatory review in the EU,” said Ruud Dobber, executive vice president of the biopharmaceuticals business unit at AstraZeneca.
“Results from the ETHOS trial should give clinicians confidence that they can reduce moderate or severe exacerbations, even during winter when respiratory diseases can put additional strain on healthcare systems,” Ferguson added.
Apart from new data with Breztri Aerosphere, AstraZeneca is presenting several abstracts at the ERS congress on its therapeutic portfolio for lung diseases like COPD and asthma.
“With 60 company abstracts accepted for presentation at ERS, there is a wealth of data across AstraZeneca’s inhaled combinations and biologic medicines, which demonstrates our commitment to advancing clinical practice in respiratory disease,” Dobber said.
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