AstraZeneca’s Breztri Aerosphere Shows Positive Phase III Results for Uncontrolled Asthma Treatment

AstraZeneca’s Breztri Aerosphere Shows Positive Phase III Results for Uncontrolled Asthma Treatment

(IN BRIEF) Positive results from the Phase III KALOS and LOGOS trials show that AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) significantly improves lung function in patients with uncontrolled asthma, compared to dual-combination ICS/LABA therapy. The trials demonstrate the potential of Breztri to evolve asthma treatment by offering an effective triple therapy for patients who remain uncontrolled with dual therapy. No new safety concerns were identified, and full results will be presented at an upcoming medical meeting.

(PRESS RELEASE) CAMBRIDGE, 2-May-2025 — /EuropaWire/ — AstraZeneca has announced positive high-level results from the Phase III KALOS and LOGOS trials, which investigated the efficacy of its fixed-dose triple-combination therapy, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF [320/28.8/9.6μg]), in patients with uncontrolled asthma. The trials showed that Breztri met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared to dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.

KALOS and LOGOS were replicate, randomised, double-blind trials designed to evaluate Breztri as a potential treatment for asthma. These trials compared the efficacy and safety of Breztri to maintenance treatment with ICS/LABA in both adults and adolescents suffering from uncontrolled asthma.

Asthma is a widespread chronic respiratory disease that causes airway inflammation and muscle tightening (bronchoconstriction), making breathing difficult. Globally, approximately 262 million people are affected by asthma, and nearly half of those using dual therapy remain uncontrolled, resulting in impaired lung function and a reduced quality of life.

Professor Alberto Papi, Chair of Respiratory Medicine at the University of Ferrara, and primary investigator of the trials, commented: “Despite advances in asthma treatments, millions of patients remain uncontrolled, leading to frequent breathlessness, coughing, and wheezing, which significantly impact daily activities. The KALOS and LOGOS results are promising and highlight the potential of budesonide/glycopyrronium/formoterol as a single inhaled triple therapy to improve asthma management in patients who remain uncontrolled with dual therapy.”

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, added: “We are thrilled with the positive results from these trials, which demonstrate that Breztri has the potential to improve the lives of millions of people with asthma. These findings build on Breztri’s well-established profile in COPD, and we are eager to present these results to regulatory authorities and bring this important treatment to a broader patient population.”

The trials revealed no new safety or tolerability concerns for Breztri. Full results from the KALOS and LOGOS trials will be submitted to regulatory authorities and presented at a forthcoming medical meeting.

Breztri is currently approved as an inhaled triple-combination therapy for the treatment of chronic obstructive pulmonary disease (COPD) in over 80 countries worldwide, including the US, EU, China, and Japan.

Notes

Asthma
Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide,3 including over 25 million in the US.6 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death.3,7 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life.4,5

KALOS and LOGOS Phase III trials
KALOS and LOGOS are replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BGF (320/28.8/9.6μg and 320/14.4/9.6μg) compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in an Aerosphere inhaler) and Symbicort pressurised metered-dose inhaler (pMDI).1,2 KALOS and LOGOS included approximately 4,400 randomised patients.

The trial design was optimised to evaluate the 320/28.8/9.6μg dose of BGF. The primary efficacy endpoints for the two individual trials were a change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 and trough FEV1 over 12-24 weeks and over 24 weeks.1,2

In addition to the two registrational trials (KALOS and LOGOS), two qualifying trials, LITHOS and VATHOS, also met their primary endpoints.8,9 LITHOS and VATHOS included approximately 1,000 randomised patients.

Breztri/Trixeo Aerosphere
Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Breztri Aerosphere in Japan, China and the US, and Trixeo Aerosphere in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an ICS, and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat adults with COPD in more than 80 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 5.5 million patients globally in 2024.10

AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca

References

1. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1. [Last accessed: May 2025].
2. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4. [Last accessed: Mayl 2025].
3. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf. [Last accessed: May 2025].
4. Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma. 2019 Mar;56(3):332-340.
5. Buhl R, et al. One-year follow up of asthmatic patients newly initiated on treatment with medium- or high-dose inhaled corticosteroid-long-acting β2-agonist in UK primary care settings. Respir Med. 2020 Feb: 162:105859.
6. U.S. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. [Online]. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. [Last accessed: May 2025].
7. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.
8. Clinicaltrials.gov. A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT05755906?limit=25&term=LITHOS&rank=1. [Last Accessed: May 2025].
9. Clinicaltrials.gov. A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma (VATHOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT05202262?limit=25&term=VATHOS&rank=1. [Last Accessed: May 2025].
10. AstraZeneca Data on File. 2025. REF-270910.

Matthew Bowden
Company Secretary
AstraZeneca PLC

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SOURCE: AstraZeneca