FDA Approves first Triple-Inhaler Therapy for Asthma

The U.S. Food and Drug Administration has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) as a single-inhaler maintenance therapy for Asthma in adults and children aged 12 years and older, marking it as the first triple therapy option in this category.

BREZTRI (320/18/9.6μg) was approved in the US in 2020 to treat adults with chronic obstructive pulmonary disease (COPD) and was prescribed to more than 6.8 million patients globally in 2025.

The approval by the US Food and Drug Administration (FDA) was based on efficacy and safety data from the Phase III KALOS and LOGOS trials investigating BREZTRI in a broad population consisting of patients with asthma, with or without a recent asthma exacerbation.3 In these trials, BREZTRI demonstrated a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled ICS/LABA.3 In a key secondary endpoint, BREZTRI also demonstrated a rapid onset of action with a significant improvement from baseline in lung function within five minutes after the first dose.3 BREZTRI is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

Njira Lugogo, MD, Clinical Professor, Division of Pulmonary and Critical Care Medicine,

Department of Internal Medicine, University of Michigan, said: “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. 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.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “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. The FDA’s approval of BREZTRI in asthma demonstrates how our innovative science continues to bring new solutions for patients with respiratory diseases.”

There are 27 million people living with asthma in the US,4 around half of whom continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing exacerbations and even death.5,6 Nearly 10 million asthma attacks still occur each year in the US.4

Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.3 There were no new safety or tolerability signals identified for BREZTRI in the trials.3

BREZTRI is a single-inhaler fixed-dose triple-combination therapy approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan. Regulatory filings for BREZTRI in asthma are currently under review in other major regions including the EU, Japan and China.