AstraZeneca's Breztri Aerosphere Shows Improvement in Uncontrolled Asthma

Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate, or BGF) demonstrated significant improvements in uncontrolled asthma when compared with a dual-combination inhaled corticosteroid (ICS) or long-acting beta2-agonist (LABA), according to an AstraZeneca news release.¹

“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,” Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said in the release. “Building on its well-established profile in COPD [chronic obstructive pulmonary disease], we hope to bring Breztri to patients with uncontrolled asthma as quickly as possible.”

For pharmacists managing respiratory patients, these findings address a critical gap in care for the estimated 262 million people worldwide living with asthma, many of whom remain uncontrolled despite adhering to dual-maintenance regimens.

READ MORE: Awareness and Treatment Combination Optimizes Asthma Outcomes

In the United States alone, the CDC reports that over 25 million people currently have asthma, with national data indicating that approximately 39.4% of these individuals experienced at least 1 asthma attack in 2021.^1,2 The persistence of symptoms like frequent breathlessness, coughing, and wheezing highlights the ongoing need for more effective long-term control medications.^1,3

KALOS and LOGOS Trial Results

The KALOS (NCT04609878) and LOGOS (NCT04609904) trials were replicate, randomized, double-blind phase 3 studies involving approximately 4300 patients across multiple centers.¹ Researchers evaluated the efficacy of Breztri Aerosphere—a combination of the ICS budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrronium, and the LABA formoterol fumarate.

In a pooled analysis of the primary endpoints, Breztri improved lung function by 76 mL as measured by morning pre-dose trough forced expiratory volume in 1 second (FEV1) and by 90 mL as measured by FEV1 over 24 weeks compared with dual ICS/LABA therapy. Furthermore, the triple therapy demonstrated a reduction in the annualized rate of severe asthma exacerbations, a benefit that was observed regardless of the patient's prior exacerbation history.

Pharmacists’ Necessary Knowledge in Managing Asthma Therapies

The American Academy of Allergy, Asthma & Immunology (AAAAI) points out that although combination inhalers containing an ICS and a LABA are standard, the addition of a LAMA like glycopyrronium provides an additional mechanism for keeping airways open by relaxing the surrounding muscles.^3-4 This triple-combination approach aims to stabilize the severe persistent asthma classification, where patients otherwise face symptoms throughout the day and frequently at night.³

From a clinical pharmacy perspective, it is vital to recognize that while Breztri is already approved for the treatment of COPD in over 80 countries, its regulatory filings for asthma are currently under review.¹

Pharmacists must counsel patients that Breztri is not a rescue inhaler and should not be used to treat acute bronchospasm; instead, a short-acting beta2-agonist like albuterol must be used for rapid symptom relief. Additionally, pharmacists should monitor for potential drug interactions, as the coadministration of Breztri with strong cytochrome P450 3A4 inhibitors can increase systemic budesonide exposure, and the excessive use of sympathomimetic drugs can lead to significant cardiovascular events.^1,3-4

Patient education remains paramount, especially regarding the risk of oropharyngeal candidiasis, which requires patients to rinse their mouths after use.^1,3

The trials reported no new safety or tolerability signals, though standard class warnings for ICS, LABA, and LAMA components apply, including vigilance for pneumonia, cardiovascular arrhythmias, and potential bone mineral density decreases with long-term use.¹ As the medical community moves toward more integrated management strategies, such as SMART/MART therapy, the potential inclusion of triple-combination therapies like Breztri could offer a new standard for patients who fail to achieve clinical remission on dual therapy alone.^1,4

“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,” concluded Alberto Papi, MD, PhD, primary trial investigator.¹ “The KALOS and LOGOS trials show that the single fixed-dose triple therapy BGF, 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.”

READ MORE: Asthma Resource Center

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REFERENCES

1. 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. News Release. AstraZeneca. February 13, 2026. Accessed February 17, 2026. https://www.astrazeneca-us.com/content/az-us/media/press-releases/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.html#

2. Most recent national asthma data. CDC. May 10, 2023. Accessed February 17, 2026. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm

3. Asthma diagnosis and treatment. Mayo Clinic. March 8, 2025. Accessed February 17, 2026. https://www.mayoclinic.org/diseases-conditions/asthma/diagnosis-treatment/drc-20369660

4. Asthma symptoms, diagnosis, management & treatment. American Academy of Allergy Asthma and Immunology. September 11, 2025. Accessed February 17, 2026. https://www.aaaai.org/Conditions-Treatments/asthma