Wilmington– AstraZeneca’s inhaled triple-combination therapy BREZTRI AEROSPHERE has met all primary endpoints in two late-stage clinical trials, showing significant improvement in lung function for patients with uncontrolled asthma compared to current dual-combination therapies.
The positive topline results from the Phase III KALOS and LOGOS trials showed that BREZTRI — a fixed-dose inhaler containing budesonide, glycopyrronium, and formoterol fumarate — delivered statistically significant and clinically meaningful improvements in lung function over standard inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) treatments.
Both KALOS and LOGOS were randomized, double-blind trials evaluating the safety and efficacy of BREZTRI in adults and adolescents with asthma inadequately controlled by dual maintenance therapy.
“Despite advances in treatment, many patients remain uncontrolled, experiencing symptoms that interfere with daily life,” said Professor Alberto Papi, primary investigator of the trials and Chair of Respiratory Medicine at the University of Ferrara in Italy. “These findings show that BREZTRI has the potential to become a more effective single-inhaler treatment option.”
Asthma affects approximately 262 million people globally, and nearly half of those receiving dual therapy continue to struggle with poor symptom control, limiting lung capacity and quality of life.
Sharon Barr, AstraZeneca’s Executive Vice President of BioPharmaceuticals R&D, said the results reinforce BREZTRI’s broader potential beyond its current use in chronic obstructive pulmonary disease (COPD). “We’re encouraged by these results and look forward to engaging with regulatory authorities to make this therapy available to more asthma patients,” she said.
No new safety or tolerability concerns were observed in either trial. Full data from KALOS and LOGOS will be submitted to regulators and presented at an upcoming medical meeting.
BREZTRI is currently approved for the treatment of COPD in more than 80 countries, including the United States, European Union, China, and Japan.
