Breztri Aerosphere is now FDA-approved for asthma, making it the first triple-combination inhaler to carry that indication. This is a recent development. For several years after its initial 2020 approval, Breztri was authorized only for chronic obstructive pulmonary disease (COPD), and its labeling explicitly stated it was not for asthma. That has changed based on clinical trial results that showed meaningful benefits for people with uncontrolled asthma.
What Changed With the Asthma Approval
When Breztri first reached the market, its prescribing information carried a clear warning: “BREZTRI AEROSPHERE is not for the treatment of asthma. It is not known if BREZTRI AEROSPHERE is safe and effective in people with asthma.” The label also flagged a specific concern: one of Breztri’s active ingredients is a long-acting beta agonist (LABA), and LABA medicines used alone have been linked to increased hospitalizations and death from asthma.
The FDA’s subsequent approval for asthma added a second indication to Breztri’s existing COPD license. The decision was based on efficacy and safety data from two Phase III clinical trials, KALOS and LOGOS, with results published in The Lancet Respiratory Medicine. Regulatory submissions for asthma are also under review in the EU, Japan, and China.
How Breztri Works
Breztri is a triple-therapy inhaler, meaning it combines three medications in a single device. Each targets airway problems through a different mechanism:
- An inhaled corticosteroid that reduces inflammation in the airways
- A long-acting muscarinic antagonist (anticholinergic) that relaxes the muscles around the airways by blocking nerve signals that cause them to tighten
- A long-acting beta agonist that also relaxes airway muscles but through a different pathway, keeping airways open for extended periods
This three-pronged approach is typically reserved for people whose asthma isn’t adequately controlled with one or two medications. The convenience of having all three in one inhaler simplifies treatment and can improve adherence compared to juggling multiple devices.
Who This Applies To
Triple therapy is not a first-line treatment for asthma. Most people start with a single inhaled corticosteroid, then add a LABA if symptoms persist. Breztri’s role is for those who remain symptomatic despite that step-up, adding the anticholinergic component as a third layer of airway control. If your asthma is well managed on your current regimen, a triple-therapy inhaler likely isn’t necessary.
The LABA safety concern mentioned in Breztri’s original labeling is worth understanding. When LABA medications are used alone, without an accompanying corticosteroid, they can worsen asthma outcomes. Inside Breztri, the LABA is always paired with a corticosteroid, which mitigates that risk. This is the same safety principle behind other combination inhalers that pair these two drug classes.
Common Side Effects
The side effect profile of Breztri reflects what you’d expect from its three components. Upper respiratory tract infections, headache, and back pain are among the most commonly reported. Oral thrush, a fungal infection in the mouth and throat caused by the steroid component, is preventable by rinsing your mouth with water after each use.
Other frequently reported effects include joint pain, muscle spasms, sinus inflammation, cough, hoarseness, nausea, difficulty sleeping, and elevated blood sugar. Some people notice heart palpitations or feelings of anxiety, both related to the LABA component’s stimulant-like action on the body.
More serious but less common concerns include pneumonia (the steroid component can slightly increase susceptibility), bone thinning with long-term use, new or worsening eye problems like glaucoma or cataracts, and urinary retention from the anticholinergic ingredient. If you experience sudden breathing problems immediately after using the inhaler, that’s a sign of paradoxical bronchospasm, a rare reaction where the medication temporarily tightens rather than relaxes the airways.
How Breztri Compares to Other Triple Inhalers
Trelegy Ellipta is the other major triple-combination inhaler on the market. It uses the same three drug classes but contains different specific medications and uses a dry powder delivery system rather than Breztri’s pressurized metered-dose format. Trelegy has carried an asthma indication for longer, so Breztri’s new approval gives patients and prescribers a second option in this category. The choice between them often comes down to inhaler technique preference, insurance coverage, and how well a patient tolerates the specific active ingredients in each.