The single-inhaler therapy Breztri Aerosphere is now indicated for maintenance treatment in adults and pediatric patients who remain symptomatic on dual therapies.
RT’s Three Key Takeaways:
- Triple Therapy Approval: The FDA approved Breztri Aerosphere as the first single-inhaler triple therapy for the maintenance treatment of asthma in patients 12 years of age and older.
- Improved Lung Function: Results from the KALOS and LOGOS Phase III trials showed that the therapy provided significant improvements in lung function and a rapid onset of action compared to dual-combination inhaled treatments.
- Uncontrolled Asthma Support: The approval addresses a clinical gap for the millions of US patients whose asthma remains uncontrolled on standard dual maintenance therapies.
AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved by the FDA for the maintenance treatment of asthma in patients 12 years of age and older, according to the company.
The single-inhaler therapy combines an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist. This approval marks the second indication for the medication in the US, following its 2020 approval for the treatment of COPD.
The FDA decision was supported by efficacy and safety data from the Phase III KALOS and LOGOS trials. These trials investigated the therapy in a broad population of patients with asthma, regardless of recent exacerbation history. In these studies, the triple therapy demonstrated a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled therapy.
A key secondary endpoint in the trials also showed a rapid onset of action, with patients experiencing a significant improvement in lung function from baseline within five minutes after the first dose. The medication is intended as a maintenance therapy and is not used to relieve sudden breathing problems or to replace a rescue inhaler.
“Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms,” said Njira Lugogo, MD, clinical professor in the division of pulmonary and critical care medicine at the University of Michigan. “The FDA approval of Breztri as the only maintenance triple therapy for people with asthma 12 years of age and older marks a pivotal moment in helping those living with this debilitating disease breathe better, sooner.”
There are approximately 27 million people living with asthma in the US, and nearly 10 million asthma attacks occur annually. According to the company, about half of these patients remain uncontrolled on dual therapies, which can lead to airway inflammation, bronchoconstriction, and potential death.
“As the fastest growing fixed-dose triple-combination therapy in COPD, Breztri is already improving outcomes for people suffering with COPD, and we are proud to extend its benefits to asthma patients,” said Ruud Dobber, executive vice president of the biopharmaceuticals business unit at AstraZeneca, in a news release.
Results from the KALOS and LOGOS trials, which included approximately 4,300 randomized patients, were published in The Lancet Respiratory Medicine in February 2026. The studies identified no new safety or tolerability signals. While the therapy is approved for COPD in 90 countries, regulatory filings for the asthma indication are currently under review in the EU, Japan, and China.
