WILMINGTON, Del. — Full results from the Phase III KALOS and LOGOS clinical trials evaluating BREZTRI Aerosphere in patients with uncontrolled asthma have been published in The Lancet Respiratory Medicine, showing statistically significant and clinically meaningful improvements in lung function and reductions in severe asthma exacerbations compared with commonly used dual-combination inhaled therapies.
The studies evaluated BREZTRI Aerosphere, a single-inhaler, fixed-dose triple combination of an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist. In the trials, BREZTRI demonstrated superior outcomes versus dual-combination inhaled corticosteroid and long-acting beta2-agonist therapies, including Symbicort, PT009, and the combined dual-therapy groups.
In a pre-specified pooled analysis of the primary endpoints across the KALOS and LOGOS trials, BREZTRI improved lung function as measured by morning pre-dose trough FEV1 over 24 weeks by 76 mL compared with dual therapy. It also improved FEV1 area under the curve from zero to three hours over 24 weeks by 90 mL versus dual therapy. Both results were statistically significant, with unadjusted p values below 0.001.
The pooled analysis further showed that BREZTRI achieved clinically meaningful reductions in the annualized rate of severe asthma exacerbations compared with inhaled corticosteroid and long-acting beta2-agonist therapies, regardless of whether patients had a recent history of exacerbations.
“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,” said Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara and primary investigator of the trials. “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 of BioPharmaceuticals Research and Development at AstraZeneca, said the company is encouraged by the findings as it looks to address unmet needs in asthma care. “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,” she said. “Building on its well-established profile in COPD, we hope to bring BREZTRI to patients with uncontrolled asthma as quickly as possible.”
No new safety or tolerability signals were identified for BREZTRI in either the KALOS or LOGOS trials, according to the published results.
BREZTRI is currently approved in more than 80 countries for the maintenance treatment of adults with chronic obstructive pulmonary disease. Regulatory applications for use of BREZTRI in asthma are under review in major global markets. Under its current labeling, BREZTRI is indicated only for COPD and is not approved for the treatment of asthma or for relief of acute bronchospasm.
