AstraZeneca’s Breztri Shows Strong Efficacy In Phase III Asthma Trials, Meeting All Primary Endpoints

AstraZeneca has announced that its triple-combination inhaler therapy, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), delivered positive top-line results in two Phase III trials—KALOS and LOGOS, conducted in patients with uncontrolled asthma. The therapy met all primary endpoints, showing statistically significant and clinically meaningful improvements in lung function compared to standard dual ICS/LABA inhalers.

Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said, “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.”  

KALOS and LOGOS were large, randomised, double-blind clinical trials evaluating the efficacy and safety of Breztri in adults and adolescents whose asthma remained uncontrolled despite dual therapy. Asthma affects 262 million people globally, and nearly half of those on current dual therapies still experience poor symptom control, leading to reduced lung function and quality of life. 

“We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that Breztri could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients,” said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.

Importantly, the trials reported no new safety or tolerability issues associated with Breztri. Already approved in over 80 countries, including the US, EU, China and Japan for treating COPD. AstraZeneca plans to present the complete trial data at an upcoming medical conference and submit it to health authorities for regulatory review.