What Is Breztri Aerosphere, and Why Does It Matter?
Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a fixed-dose prescription medicine that combines three medications and is commonly used as a daily maintenance inhaler for managing long-term respiratory disorders such as chronic obstructive pulmonary disease (COPD). The FDA has now approved Breztri Aerosphere as the only single-inhaler triple therapy in the U.S. for maintenance control of asthma in patients ages 12 years or older.
Asthma is a common long-term respiratory condition affecting about 262 million people globally, including around 27 million in the U.S. It causes inflammation and tightening of the airways (bronchoconstriction), leading to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. And in severe cases, it can be life-threatening.
Even with standard treatments, many people still struggle to keep their asthma under control, which can limit their daily activities and affect quality of life. In the U.S. alone, asthma remains uncontrolled in nearly half of patients on standard dual therapies, and about 10 million asthma attacks occur each year.
Breztri Aerosphere is a fixed-dose combination of three medicines – budesonide, glycopyrrolate, and formoterol fumarate – in one inhaler. Budesonide is an inhaled corticosteroid with a strong anti-inflammatory activity that reduces inflammation and swelling. Glycopyrrolate is a long-acting muscarinic antagonist (anticholinergic agent) that helps keep muscles around the airways relaxed. Formoterol fumarate selectivity binds to beta-2 adrenoceptors present in the airways, helping the airways open up (bronchodilation). Together, these medicines help prevent and control symptoms of asthma, making breathing easier. But Breztri Aerosphere does not treat sudden breathing problems, so you still need a fast-acting rescue inhaler for flare-ups.
Breztri Aerosphere was first approved in 2020 to help maintain control of COPD in adults. This approval matters because Breztri Aerosphere may make maintenance treatment of asthma in patients ages 12 years or older simpler than using multiple inhalers, while addressing both airway inflammation and narrowing at the same time.
Why Was It Approved?
The FDA's approval was based on data from two clinical studies that showed that Breztri Aerosphere was safe and effective in improving lung function in patients ages 12 years or older whose asthma remained uncontrolled on two-medicine inhalers containing an inhaled steroid plus a long-acting beta-2 agonist.
In two clinical trials involving about 4,300 patients with asthma, with or without a recent flare-up, Breztri Aerosphere was compared against the two-medicine inhalers Symbicort and PT009 (both containing budesonide/formoterol fumarate). The studies lasted between 24 and 52 weeks. The results showed that Breztri Aerosphere significantly improved lung function and started working quickly – within about five minutes of the first dose. Pooled results showed that severe asthma attacks happened a bit less often with Breztri Aerosphere than with the two-medicine inhalers, although the difference was small.
No new safety concerns were seen for Breztri Aerosphere in these studies. Across studies, common side effects included upper respiratory infections, pneumonia, thrush (a mouth yeast infection), coughing, inflammation of the sinuses, diarrhea, back pain, flu, muscle spasms, urinary tract infections, nausea, headaches, palpitations, high blood sugar levels, and hoarseness.
What Do I Need to Know?
Prime the inhaler before first use by releasing four sprays into the air. Use Breztri Aerosphere by inhaling two puffs two times a day (two in the morning and two in the evening) through your mouth. Do not take more than two puffs twice daily. Rinse your mouth with water and spit after each dose to lower the chance of thrush. Prime your inhaler again if you have not used it for more than seven days, if you drop it, or after you rinse the device each week.
Before using Breztri Aerosphere, let your health care provider know about all your medical conditions, especially if you have heart or blood pressure problems, seizures, thyroid issues, diabetes, liver or kidney disease, osteoporosis, a weakened immune system, eye conditions such as glaucoma or cataracts, prostate or bladder problems including a hard time passing urine, any type of infection (viral, bacterial, parasitic, or fungal), or exposure to chickenpox or measles, as the medication may worsen some of these conditions.
Your health care provider will check your bone strength and blood sugar and potassium levels at the start of treatment and may continue to monitor them regularly. Children receiving Breztri Aerosphere will need routine checks to track their growth.
Share a list of all medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Breztri Aerosphere may interact with antifungal or anti-HIV medications, atropine, and similar respiratory medicines, which could lead to serious side effects. While using it, do not use other inhalers that contain medicines similar to the ones in Breztri Aerosphere, such as other long-acting beta-agonists and anticholinergics, unless your health care provider tells you to do so. Do not use Breztri Aerosphere if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the ingredients in the inhaler.
Tell your health care provider if you are pregnant, planning to become pregnant, or breastfeeding, as it is not known whether Breztri Aerosphere may harm a fetus or whether it passes into breast milk.
Breztri Aerosphere does not work for sudden breathing problems. Always keep a rescue inhaler with you. Seek medical care right away if your rescue inhaler seems less effective, if you need more puffs than usual, or if you have sudden breathing problems right after inhaling your medicine.
Call your health care provider right away if you notice any symptoms of infection or pneumonia (such as fever, chills, a hard time breathing, or increased cough or mucus [sputum] production), signs of an allergic reaction (such as swelling of the face, lips, mouth, tongue, or throat; itching; hives; or a skin rash), chest pain, an irregular heartbeat, tremors or nervousness, new or worsening eye problems (such as eye pain, blurred vision, or seeing halos or bright colors around lights), or difficulty or pain during urination. These could be signs of serious side effects.