Full results from the Phase III KALOS and LOGOS trials show that AstraZeneca’s triple-combination inhaler Breztri Aerosphere delivered statistically significant and clinically meaningful improvements in patients with uncontrolled asthma when compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies.
The studies, published in The Lancet Respiratory Medicine, evaluated Breztri against standard dual-therapy comparators, including budesonide/formoterol fumarate formulations and pooled ICS/LABA treatment groups.
Breztri is a single-inhaler, fixed-dose triple therapy combining an inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA).
It is approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide, including the US, EU, China and Japan.
In a pre-specified pooled analysis of primary endpoints across both trials, treatment with the triple therapy demonstrated significant improvements in lung function during 24 weeks.
Morning pre-dose trough FEV1 increased by 76 mL, while FEV1 AUC0–3 improved by 90 mL compared with combined ICS/LABA therapies.
Beyond lung function outcomes, pooled data also indicated clinically meaningful reductions in the annualised rate of severe asthma exacerbations versus dual-combination treatments.
These benefits were observed in patients regardless of recent exacerbation history, highlighting the potential role of triple-combination inhaler formulations in addressing unmet needs in uncontrolled asthma management.
The publication of the full dataset provides further insight into the clinical performance of fixed-dose triple inhaler combinations, reinforcing ongoing industry interest in advanced combination drug delivery platforms for respiratory disease treatment.
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: "Many of the 262 million people worldwide living with asthma remain uncontrolled and still struggle with symptoms such as frequent breathlessness, coughing and wheezing despite the use of dual maintenance therapy."
"The KALOS and LOGOS trials show that the single fixed-dose triple therapy budesonide/glycopyrronium/formoterol... improved lung function and, importantly, prevented future severe exacerbations in patients, regardless of exacerbation history."
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "With so many patients still experiencing the debilitating effects of uncontrolled asthma, we are excited about the potential for Breztri to improve lung function as well as prevent exacerbations in asthma."
"Building on its well-established profile in COPD, we hope to bring Breztri to patients with uncontrolled asthma as quickly as possible."
There were no new safety or tolerability signals identified for Breztri in KALOS or LOGOS.