AstraZeneca’s Breztri Aerosphere demonstrated statistically significant and clinically meaningful improvements in patients with uncontrolled asthma compared with other pharmacology.


RT’s Three Key Takeaways:

  1. Triple Therapy Outperforms Dual Inhalers: Full Phase III KALOS and LOGOS results published in The Lancet Respiratory Medicine showed that Breztri Aerosphere significantly improved lung function and reduced severe asthma exacerbations compared with dual ICS/LABA therapies such as Symbicort.
  2. Clinically Meaningful Lung Function Gains: In pooled analyses, Breztri improved key lung function measures (including pre-dose FEV1 and FEV1 AUC0-3 over 24 weeks) and lowered annualized severe exacerbation rates in patients with uncontrolled asthma, regardless of prior exacerbation history.
  3. Potential Expansion Beyond COPD: Already approved in more than 80 countries for COPD by AstraZeneca, Breztri showed no new safety concerns in asthma trials, with regulatory reviews for asthma indications now underway globally.


Full results from the positive Phase III KALOS and LOGOS trials published in The Lancet Respiratory Medicine showed AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) demonstrated statistically significant and clinically meaningful improvements in patients with uncontrolled asthma compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines: Symbicort (budesonide/formoterol fumarate or BFF, a standard therapeutic option), PT009 (BFF in an Aerosphere formulation) and the Symbicort and PT009 treatment groups combined.1 Breztri is a single-inhaler, fixed-dose triple-combination of ICS/LABA and a long-acting muscarinic antagonist (LAMA). 

In a pre-specified pooled analysis of the primary endpoints across the KALOS and LOGOS trials, Breztri improved lung function by 76mL (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks) and 90mL (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks) versus dual therapy (the ICS/LABA treatment groups combined).1  

In the pooled analysis of KALOS and LOGOS, Breztri also demonstrated clinically meaningful reductions in the annualised rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. Full results can be found in The Lancet Respiratory Medicine.  

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 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, which combines the efficacy of an ICS, LAMA, and LABA, 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.”