FDA Clears First Single-Inhaler Triple Therapy for Asthma

In April 2026, the FDA approved budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere; AstraZeneca) for maintenance treatment of asthma in adults and pediatric patients 12 years and older, establishing it as the first and only single-inhaler triple combination therapy for this indication in the US.^1,2

The approval delivers a combined inhaled corticosteroid (ICS), long-acting β2-agonist (LABA), and long-acting muscarinic antagonist (LAMA) through a single pressurized metered-dose inhaler, offering a streamlined option for patients who remain symptomatic on dual maintenance regimens.^1,2

Pharmacology and Pharmacokinetics

Budesonide/glycopyrrolate/formoterol fumarate delivers 3 pharmacologically distinct components through the Aerosphere pressurized metered-dose inhaler platform. Budesonide is an ICS that reduces airway inflammation by modulating glucocorticoid receptors, thereby decreasing the production of inflammatory mediators central to asthma pathophysiology. Glycopyrrolate is a LAMA that provides bronchodilation by blocking muscarinic M3 receptors in airway smooth muscle, reducing bronchoconstriction. Formoterol fumarate is a long-acting, fast-onset β2-adrenergic receptor agonist that promotes bronchodilation through activation of β2 receptors.^1,2

The combination of all 3 mechanisms in a single inhaler addresses the inflammatory and bronchoconstrictive components of asthma simultaneously. The Aerosphere platform was originally approved in more than 90 countries for the treatment of chronic obstructive pulmonary disease (COPD) before this asthma indication was granted.^1,2

Clinical Trials

The regulatory approval was supported by data from the phase 3 KALOS (NCT04609878) and LOGOS (NCT04609904) trials, which were replicate, randomized, double-blind, double-dummy, parallel-group studies involving approximately 4300 patients in total. These trials enrolled a broad patient population, including individuals with and without a history of recent exacerbations.^3,4

Both studies demonstrated statistically significant and clinically meaningful improvements in lung function with the triple combination therapy compared with dual ICS/LABA treatment. A notable secondary end point from both trials was to show a rapid onset of action, with improvements in lung function observed within 5 minutes of the first dose. No new safety or tolerability signals were identified during the trials, reinforcing confidence in the product's long-term safety profile.^3,4

Safety Profile

The overall safety and tolerability profile of budesonide/glycopyrrolate/formoterol fumarate observed across the KALOS and LOGOS trials was consistent with the established profile of the individual components and with the product's approved COPD indication. No new or unexpected safety signals were identified in the asthma population.^1,3,4

Dosing and Administration

Budesonide/glycopyrrolate/formoterol fumarate is administered by oral inhalation twice daily. The recommended dose delivers 160 mcg of budesonide, 9 mcg of glycopyrrolate, and 4.8 mcg of formoterol fumarate per actuation, with 2 inhalations per dose. The product is approved for use in adults and pediatric patients 12 years and older.¹

REFERENCES

1. Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older. News release. AstraZeneca. April 28, 2026. Accessed May 12, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/breztri-approved-in-the-us-for-asthma.html

2. Antrim A. FDA expands respiratory options with first single-inhaler triple therapy for asthma maintenance. Pharmacy Times. May 8, 2026. Accessed May 12, 2026. https://www.pharmacytimes.com/view/fda-expands-respiratory-options-with-first-single-inhaler-triple-therapy-for-asthma-maintenance

3. Papi A, Wise RA, Jackson DJ, et al; KALOS and LOGOS study investigators. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026;14(4):350-362. doi:10.1016/S2213-2600(25)00457-6

4. Breztri met primary endpoints in KALOS and LOGOS phase III trials in asthma. News release. AstraZeneca. May 2, 2025. Accessed May 8, 2026. https://www.astrazeneca-us.com/media/press-releases/2025/Breztri-met-primary-endpoints-in-kalos-and-logos-phase-III-trials-in-asthma.html