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

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 AUC_0-3 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.”

There were no new safety or tolerability signals identified for Breztri in KALOS or LOGOS.

Breztri is an inhaled triple-combination therapy 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. Regulatory filings for Breztri in asthma are currently under review in all major regions.