At a Glance
- KALOS/LOGOS Phase III trials publish full results in The Lancet Respiratory Medicine.
- Breztri (ICS/LAMA/LABA triple) beats Symbicort/PT009 duals on lung function and exacerbations.
- Gains: +76 mL trough FEV1, +90 mL FEV1 AUC0-3 (24 weeks, p<0.001); no new safety signals.
- COPD-approved (>80 countries); asthma filings under review worldwide.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
AstraZeneca’s announced single-inhaler triple therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate, or BGF at 320/28.8/9.6μg) combining an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and long-acting beta2-agonist (LABA) significantly outperformed dual ICS/LABA therapies in patients with uncontrolled asthma, per full Phase III KALOS and LOGOS results published in The Lancet Respiratory Medicine.
In a pre-specified pooled analysis of over 4,300 patients across the replicate, double-blind trials, Breztri delivered statistically significant improvements in lung function versus combined Symbicort (budesonide/formoterol fumarate, or BFF) and PT009 (BFF Aerosphere) groups. Morning pre-dose trough FEV1 rose by 76 mL (95% CI 57-94 mL, unadjusted p<0.001) over 24 weeks, while FEV1 AUC0-3 increased by 90 mL (95% CI 72-108 mL, unadjusted p<0.001).
Breztri also cut annualized severe asthma exacerbation rates versus dual therapies, with benefits seen in patients with or without recent exacerbations. No new safety signals emerged.
Primary investigator Alberto Papi, Professor of Respiratory Medicine at the University of Ferrara and primary investigator, highlighted the impact: “Many of the 262 million people worldwide with asthma remain uncontrolled despite dual therapy, facing breathlessness, coughing, and wheezing. KALOS and LOGOS demonstrate that this fixed-dose ICS/LAMA/LABA triple therapy boosts lung function and prevents severe exacerbations, regardless of history.”
Sharon Barr, Executive VP of BioPharmaceuticals R&D at AstraZeneca, added “Uncontrolled asthma affects millions; Breztri’s profile in improving lung function and curbing exacerbations builds on its COPD success. We’re pushing for swift approvals.”
Trial and Asthma Context
KALOS and LOGOS were 24-to-52-week, multicenter studies comparing Breztri (320/28.8/9.6μg and 320/14.4/9.6μg) to Symbicort pMDI and PT009. Primary endpoints focused on FEV1 changes at Week 24 and trough FEV1 over 24 weeks. Qualifying trials LITHOS and VATHOS (n≈1,000) also hit endpoints.
Asthma impacts 262 million globally, including 25 million in the US, causing bronchoconstriction, symptoms, and mortality when uncontrolled despite standard therapies limiting quality of life.
Approved as Breztri Aerosphere (US, Japan, China) or Trixeo Aerosphere (EU) for COPD in over 80 countries, it reached 5.5 million patients in 2024. Asthma regulatory submissions are under review worldwide.
References
Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for Breztri in patients with uncontrolled asthma published in The Lancet Respiratory Medicine, 13 February 2026, Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for Breztri in patients with uncontrolled asthma published in The Lancet Respiratory Medicine
Papi, Alberto et al., Budesonide–glycopyrronium–formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials, The Lancet Respiratory Medicine, Volume 0, Issue 0, https://doi.org/10.1016/S2213-2600(25)00457-6
Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) (KALOS), ClinicalTrials.gov ID NCT04609878, https://clinicaltrials.gov/study/NCT04609878
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (LOGOS), ClinicalTrials.gov ID NCT04609904, https://clinicaltrials.gov/study/NCT04609904