AstraZeneca’s Breztri Meets Primary Endpoints in Duo of Phase III Asthma Trials
The single-inhaler demonstrated a meaningful improvement in lung function in the Phase III KALOS and LOGOS studies.
AstraZeneca has announced positive results from the Phase III KALOS and LOGOS clinical trials of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) in patients with uncontrolled asthma. The fixed-dose, triple-combination therapy met all primary endpoints across both trials, achieving a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.1
In a press release, 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: “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.”
The Phase III KALOS and LAGOS trials are replicate confirmatory, randomized, double-blind, double-dummy, parallel group, multi-center studies. The trials shared the same primary endpoint of change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours at 24 weeks and trough FEV1 over 12-24 weeks and over 24 weeks. Approximately 4,400 patients were randomized across both trials.
In the press release, Sharon Barr, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that Breztri could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.”
AstraZeneca plans to share more detailed results from KALOS and LAGOS at an upcoming medical meeting.
As mentioned by Barr, Breztri already has an established profile in the treatment of chronic obstructive pulmonary disease (COPD). It was approved for the maintenance treatment of COPD in July 2020 based on positive outcomes from the Phase III ETHOS trial. In the study, Breztri demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies glycopyrrolate/formoterol fumarate and PT009 (budesonide/formoterol fumarate).2
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. Even a single exacerbation can have a negative impact on a patient’s lung function and quality of life, and it can increase the risk of death. Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD,” Fernando J. Martinez, MD, chief of division of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, New York, US and Investigator in the ETHOS trial, said in a press release from the time of the approval.
The research of Breztri in COPD is ongoing. In March 2024, AstraZeneca announced the initiation of THARROS, another Phase III trial investigating Breztri’s potential to improve cardiopulmonary outcomes in patients with COPD. According to the company, it is the first-ever prospective study to investigate the potential of an inhaled, triple therapy to reduce cardiopulmonary events.3
In a press release from the time, Barr said: “We have an important and urgent mission to eliminate COPD as a leading cause of death. Even moderate COPD exacerbations are associated with increased risks of further lung events, severe cardiovascular complications and have been shown to contribute to patients dying. With the first-of-its-kind THARROS study, we aim to demonstrate the potential of triple therapy to address cardiopulmonary risk.”
References
1. Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma. News release. AstraZeneca. May 2, 2025. Accessed May 5, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/breztri-met-primary-endpoints-in-ph3-asthma-trials.html
2. BREZTRI AEROSPHERE approved in the US for the maintenance treatment of COPD. News release. AstraZeneca. July 24, 2020. Accessed May 5, 2025. https://www.businesswire.com/news/home/20200724005241/en/BREZTRI-AEROSPHERE-approved-in-the-US-for-the-maintenance-treatment-of-COPD
3. AstraZeneca announces initiation of THARROS – a Phase III clinical trial investigating the potential of BREZTRI to improve cardiopulmonary outcomes in people with COPD. News release. AstraZeneca. March 13, 2024. Accessed May 5, 2025. https://www.businesswire.com/news/home/20240313439976/en/AstraZeneca-announces-initiation-of-THARROS-a-Phase-III-clinical-trial-investigating-the-potential-of-BREZTRI-to-improve-cardiopulmonary-outcomes-in-people-with-COPD
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