AstraZeneca‘s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function when compared to dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medications, according to positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma.
The purpose of the duplicate, randomized, double-blind KALOS and LOGOS trials was to examine Breztri as a possible asthma medication. In adults and adolescents with uncontrolled asthma, the trials compared the safety and effectiveness of Breztri to maintenance treatment with ICS/LABA.
Inflammation and bronchoconstriction, or tightening of the airway muscles, are hallmarks of asthma, a prevalent, chronic respiratory disease that can make breathing challenging. Asthma affects up to 262 million people globally, and it is believed that almost half of those receiving dual therapy do not have control over their condition, which can severely impair lung function and lower quality of 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. 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.
Alberto Papi
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.
Sharon Barr
KALOS and LOGOS Phase III Clinical Trials
In order to evaluate the safety and effectiveness of BGF (320/28.8/9.6μg and 320/14.4/9.6μg) in comparison to two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in an Aerosphere inhaler) and Symbicort pressurized metered-dose inhaler (pMDI), KALOS and LOGOS are replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24- to 52-week variable length Phase III trials. In KALOS and LOGOS, about 4,400 patients were randomly assigned.
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