Full results from the Phase 3 KALOS and LOGOS trials have been published in The Lancet Respiratory Medicine.

The results show that Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate, BGF 320/28.8/9.6 μg) demonstrated improvements in lung function and reductions in severe asthma exacerbations in patients with uncontrolled asthma compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies.

The dual therapies included Symbicort (budesonide/formoterol fumarate, BFF), PT009 (BFF in an Aerosphere formulation), and the combined ICS/LABA treatment groups.

Breztri is a single-inhaler, fixed-dose triple therapy combining an ICS, long-acting muscarinic antagonist (LAMA), and LABA. In a pre-specified pooled analysis of the KALOS and LOGOS trials, Breztri improved lung function by 76 mL (95% CI 57–94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks) and 90 mL (95% CI 72–108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks) compared with dual therapy groups combined.

The pooled analysis also showed that Breztri reduced the annualised rate of severe asthma exacerbations versus ICS/LABA therapies in patients both with and without a recent history of exacerbation. No new safety or tolerability signals were identified for Breztri in either trial.

Alberto Papi, professor and chair of respiratory medicine at the University of Ferrara and director of the respiratory unit at 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 like 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, added: “With so many patients still experiencing the debilitating effects of uncontrolled asthma, we are interested in Breztri’s potential to improve lung function and prevent exacerbations. Building on its established profile in COPD, the therapy may offer a treatment option for patients with uncontrolled asthma as regulatory approvals progress.”

Breztri is currently approved as an inhaled triple-combination therapy for chronic obstructive pulmonary disease (COPD) in adults in over 80 countries, including the US, EU, China, and Japan. Regulatory filings for asthma are under review in major regions.