Pharmaceutical company AstraZeneca announced the results of its Breztri Aerosphere phase III KALOS and LOGOS clinical trials. In a press release, the company said its yet-to-be-published research, “Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) (KALOS),” successfully met all primary endpoints in the trials, demonstrating significant improvements in lung function for patients with uncontrolled asthma. Breztri Aerosphere is already approved for the treatment of COPD in more than 80 countries, including the United States.
The study evaluated approximately 4,400 adults and adolescents with uncontrolled asthma to compare Breztri Aerosphere (BGF 320/28.8/9.6 µg) to dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies. KALOS and LOGOS were replicate confirmatory, randomized, double-blind trials measuring changes in forced expiratory volume in one second (FEV1) and trough FEV1 over 24 weeks.
“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 Alberto Papi, MD, PhD, professor of respiratory medicine at the University of Ferrara in Italy and the study’s primary investigator. “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.”
Researchers said Breztri Aerosphere demonstrated no new safety or tolerability concerns in the KALOS and LOGOS trials. Full results from the trials will be shared with regulatory authorities and presented at an upcoming medical meeting.
