Managing Your Condition/Living With Asthma

FDA Approves First Triple-Therapy Inhaler for Asthma

Written by Ted Samson

Posted on June 22, 2026

Feel better informed on asthma and get real support from your community.

The U.S. Food and Drug Administration (FDA) has approved Breztri Aerosphere, an inhaler that contains three medicines. Breztri Aerosphere contains budesonide, glycopyrrolate, and formoterol fumarate, a combination referred to as BGF. The inhaler is for the maintenance treatment of asthma in adults and children ages 12 and older.

In phase 3 clinical trials, the inhaler improved lung function compared with inhalers containing two medications, an inhaled corticosteroid and a long-acting beta-2 agonist (LABA).

This approval makes Breztri the first and only FDA-approved single-inhaler triple therapy for asthma in people ages 12 and older. It gives healthcare providers a new type of maintenance treatment option for asthma.

Share your thoughts.

🗳️ What type of asthma inhaler do you or your loved one use to help manage asthma?

A daily maintenance (preventive) inhaler

A rescue (quick-relief) inhaler

Both maintenance and rescue inhalers

I (or they) don’t currently use asthma inhalers.

What Is Breztri?

This newly approved maintenance inhaler combines three medicines in one inhaler:

Budesonide is an inhaled corticosteroid, which helps reduce airway inflammation.
Formoterol is a LABA, which helps relax muscles around the airways.
Glycopyrrolate is a long-acting muscarinic antagonist, which also helps keep the airways open.

Many asthma maintenance inhalers use two medicines, often an inhaled corticosteroid plus a LABA. The BGF combination adds a third type of medicine, a long-acting muscarinic antagonist, in the same inhaler.

What Did Clinical Trials Show?

The FDA approval was based on results from the KALOS and LOGOS phase 3 clinical trials. These trials included about 4,300 people ages 12 to 80 with asthma that wasn’t well controlled based on the results of lung function tests.

Participants received the BGF combination or one of two dual-therapy inhalers. Researchers measured lung function using FEV1, a lung function test that measures how much air a person can forcefully breathe out in one second. They also looked at severe asthma flares, also called exacerbations.

Key findings included:

Improved morning lung function — Over 24 weeks, people taking BGF had better morning lung function than people taking dual therapy. The difference was 76 milliliters in FEV1 compared with the combined dual-therapy groups.
Better lung function after dosing — The BGF combination also improved lung function during the first three hours after a dose. The difference was 90 milliliters in FEV1 compared with the combined dual-therapy groups.
Fewer severe asthma flares — BGF reduced the rate of severe asthma exacerbations compared with the combined dual-therapy groups. The rate was 14 percent lower in people using the three-drug combination compared with the two-drug regimens.

What Are the Possible Side Effects?

All medications can cause side effects. Some side effects may be mild, while others may need medical attention.

In asthma studies, the most common side effects of BGF were:

Nasopharyngitis (coldlike symptoms)
Pneumonia
Headache

The drug’s prescribing label also has important safety warnings. Among them:

The medication should not be used as a rescue inhaler for sudden breathing symptoms.
People using inhaled medicines that contain corticosteroids may be advised to rinse their mouth with water and spit after use to help lower the risk of oral thrush, a yeast infection in the mouth.

Why This Approval Matters for People With Asthma

Asthma is a chronic lung condition that can cause symptoms such as wheezing, shortness of breath, chest tightness, and coughing. When asthma isn’t well controlled, inflammation and tightening in the airways can make breathing harder and may increase the risk of asthma attacks.

The approval of the BGF combination adds a new maintenance treatment option for people ages 12 and older.

If your asthma or your child’s asthma isn’t well controlled, consider asking a healthcare provider whether it’s time to discuss other maintenance treatment options.