WILMINGTON, DE — AstraZeneca has announced positive high-level results from its Phase III KALOS and LOGOS trials, showing significant promise for its fixed-dose triple-combination therapy, BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF), in treating uncontrolled asthma. Conducted as randomized, double-blind studies, the trials demonstrated that BREZTRI significantly improved lung function compared to dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies.
Asthma remains a major global health challenge, affecting 262 million people worldwide, with nearly half of patients on dual therapy failing to achieve control. Uncontrolled asthma often results in breathlessness, coughing, and wheezing, severely impacting daily life.
“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,” said Professor Alberto Papi, lead investigator and Chair of Respiratory Medicine at the University of Ferrara. “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.”
BREZTRI, already approved in over 80 countries for chronic obstructive pulmonary disease (COPD), may now offer hope to asthma sufferers. “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,” said Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca. “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.”
The trials identified no new safety or tolerability concerns. Full results will be submitted to regulatory authorities and shared at an upcoming medical meeting. This breakthrough strengthens AstraZeneca’s position in redefining the standard of care for respiratory diseases.
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