The U.S. Food and Drug Administration has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of asthma in adults and adolescents aged 12 and older. The approval, announced on April 28, 2026, makes Breztri the first single-inhaler triple therapy authorized for asthma in patients as young as 12 — extending a treatment category that previously had no FDA-approved option for adolescents.
For patients who remain uncontrolled on dual-therapy inhalers, and particularly for adolescents who until now had no triple-therapy option, this represents a meaningful addition to the asthma treatment landscape.
What Is Breztri?
Breztri Aerosphere is a pressurized metered-dose inhaler that combines three active medications in a single device: budesonide (an inhaled corticosteroid, or ICS), glycopyrrolate (a long-acting muscarinic antagonist, or LAMA), and formoterol fumarate (a long-acting beta2-agonist, or LABA).
Single-inhaler triple therapy — combining ICS, LABA, and LAMA into one device — has been available for adult asthma patients since GSK’s Trelegy Ellipta received FDA approval in 2020. Breztri’s approval extends that option to patients aged 12 and older, filling a gap that left adolescents without an equivalent single-inhaler option.
Breztri was previously approved in the U.S. in 2020 for the maintenance treatment of COPD in adults, where it has since been prescribed to more than 6.8 million patients globally.
Why This Approval Matters
Asthma affects an estimated 27 million people in the United States. Despite the availability of dual-therapy inhalers, roughly half of those patients remain inadequately controlled — continuing to experience daily breathing difficulties, reduced lung function, and recurrent exacerbations.
Dr. Njira Lugogo, clinical professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan, noted that many patients on dual maintenance therapy are still at risk for exacerbations and ongoing breathing difficulties, and described the approval as a meaningful step toward helping patients breathe better sooner.
Breztri was evaluated in a broad asthma population, including patients with and without a recent exacerbation history — reflecting the range of patients seen in real-world allergy and pulmonary practices.
What the Clinical Trials Showed
The FDA’s decision was based on data from two Phase III trials — KALOS and LOGOS — which together enrolled approximately 4,300 patients with asthma.
Across both trials, Breztri demonstrated statistically significant and clinically meaningful improvements in lung function compared with dual ICS/LABA therapy. The primary endpoint measured change from baseline in FEV1 over the first three hours at week 24. A key secondary endpoint showed significant improvement in morning pre-dose trough FEV1 at the same timepoint.
Lung function improvement was observed within five minutes of the first dose. No new safety or tolerability signals were identified compared with Breztri’s established COPD profile.
Breztri is a maintenance treatment only. It is not a rescue inhaler and is not intended to relieve sudden breathing problems.
What This Means for Asthma Patients
For patients already on a two-drug inhaler who continue to experience uncontrolled symptoms, For adult patients already on a two-drug inhaler who continue to experience uncontrolled symptoms, Breztri offers an additional step-up option before escalating to biologic therapy. For adolescents aged 12 to 17, it represents the first time a single-inhaler triple therapy has been specifically approved for their age group — previously, no such option existed.
Consolidating three drug classes into one device may also support medication adherence for patients managing complex treatment regimens.
Regulatory submissions for Breztri in asthma are currently under review in the EU, Japan, and China.
If you or someone in your family is living with asthma that remains poorly controlled on current treatment, speak with one of our board-certified allergists about whether a triple-therapy approach may be appropriate. NY Allergy & Sinus Centers offers comprehensive asthma evaluation and management across our New York locations. Contact our office at (212) 686-6321 to schedule a consultation.