FDA Clears Breztri for Asthma Use

Single-inhaler triple therapy improved lung function vs dual therapy in phase 3 trials and showed rapid onset without new safety signals.

By
Kathryn Wighton
April 28, 2026
2 min

Conexiant

Overview

The FDA has approved budesonide/glycopyrrolate/formoterol fumarate (Breztri) as a fixed-dose triple-combination inhaler for maintenance treatment of asthma in patients aged 12 and older. Phase 3 trials demonstrated significant improvements in lung function compared to dual therapy, with rapid onset and no new safety concerns.

Background

Asthma affects approximately 27 million people in the US, with about half remaining uncontrolled despite dual maintenance therapies. Persistent airway inflammation and bronchoconstriction cause symptoms such as wheezing, dyspnea, chest tightness, and frequent exacerbations. Current dual therapies often fail to fully control symptoms or prevent attacks, highlighting the need for more effective maintenance options. Breztri combines an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist in a single inhaler.

Data Highlights

Parameter	Outcome	Timeframe
Forced Expiratory Volume in 1 second (FEV1)	Improved over ICS/LABA therapy	First 3 hours at 24 weeks
Trough Lung Function	Improved	12 to 24 weeks and at 24 weeks
Onset of Action	Improvement within 5 minutes of initial dose	Initial dosing
Patient Population	~4,300 randomized patients with asthma	Phase 3 KALOS and LOGOS trials

Key Findings

FDA approved Breztri (budesonide/glycopyrrolate/formoterol fumarate) for asthma maintenance in patients ≥12 years old.
Phase 3 KALOS and LOGOS trials included ~4,300 patients with and without recent exacerbations.
Triple therapy improved lung function (FEV1) significantly compared to ICS/LABA dual therapy.
Rapid onset of action observed with lung function improvement within 5 minutes of first dose.
No new safety or tolerability issues identified during trials.
Therapy is for maintenance use only and not intended for acute bronchospasm relief.

Clinical Implications

Breztri offers a new maintenance treatment option for asthma patients inadequately controlled on dual therapy, potentially reducing exacerbations and improving daily lung function. Its rapid onset and triple mechanism may enhance symptom control and patient adherence. Clinicians should note it is not a rescue inhaler and should be used as part of a long-term management plan.

Conclusion

The FDA approval of Breztri expands therapeutic options for asthma maintenance, providing improved lung function and rapid symptom control without new safety concerns. This triple-combination inhaler addresses unmet needs in patients inadequately controlled on existing dual therapies.