What is the purpose of Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate)?

Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) is a triple-combination drug used for long-term maintenance of patients with chronic obstructive pulmonary disease (COPD). It is available in inhaler form, with either 28 or 120 inhalations, containing 160 mcg budesonide, 9 mcg glyrrolate, and 4.8 mcg formoterol fumarate. The substance is effective in reducing symptoms of COPD, and it can enhance the quality of life.

How does Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) function?

Chronic lung inflammation causes airway obstruction in COPD patients, which is a progressive illness mainly irreversible and the third-leading cause of death worldwide. Breztri Aerosphere combines three active compounds to enhance efficacy.

Budesonide is a corticosteroid that is anti-inflammatory. Inhaled corticosteroids are commonly used for COPD treatment.

Glyrrolate is an anticholinergic that works as a long-acting bronchodilator. It relaxes muscle cells in the lungs and widens airways, allowing easier breathing.

Formoterol fumarate is a fast-acting and long-acting selective beta2-adrenergic agonist (beta2-agonist). It functions as a bronchodilator that activates beta2 receptors resulting in the relaxation of lung muscle cells.

Breztri Aerosphere altogether provides improved symptom reduction and maintenance therapy of COPD.

Where has Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) been approved?

The United States Food and Drug Administration (FDA) approved Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) for COPD maintenance therapy on July 24, 2020. It was also approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on June 19, 2020. The drug nabbed approval on December 23, 2019, under the brand name PT010, from China’s National Medical Products Administration (NMPA). It is possible that the medication is already approved in other areas. Please contact our support team if you need information on the approvals of the drug in a specific country.

What is the method of administration for Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate)?
The standard dose range is 320 mcg budesonide, 18 mcg glyrrolate, and 9.6 mcg formoterol fumarate. Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) is breathed in through an inhaler twice daily. Two inhalations are required for each dosage, and patients are cautioned not to take more than the recommended dosage. The Breztri Aerosphere canister has an attached dose indicator to monitor the remaining inhalations. Patients should only apply the inhaler with the dose indicator to allow for maximum efficacy of the medication directed towards the lungs.

Please check with your physician for personalized dosing and possible drug interactions.

Are there any harmful reactions or side effects of Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) that are cosiderable?

The most prevalent adverse reactions (≥20% of patients) listed in the prescribing information are upper respiratory tract infection, pneumonia, back pain, thrush in the mouth and throat, joint pain, flu, headache, high blood sugar, muscle spasms, cough, inflammation of the sinuses, diarrhea, hoarseness, painful and frequent urination, nausea, difficulty sleeping, feeling anxious, and palpitations.

The serious adverse reactions listed include fungal infection in the mouth or throat (thrush), pneumonia, immunosuppression, reduced adrenal function, sudden breathing difficulties after inhaling medication, serious allergic reactions, increased blood pressure, cardiac effects, neurological effects, osteoporosis, new or worsened eyesight, urinary retention, and changes in laboratory blood values.

Breztri Aerosphere is not advisable for pregnant women, and it can be dangerous for the fetus and while breastfeeding.

For a comprehensive list of adverse reactions and side effects, please consult the official prescribing information.

Clinical trials

The Pharmaceuticals and Medical Devices Agency (PMDA) approval of Breztri Aerosphere (budesonide/glyrrolate/formoterol fumarate) in Japan for COPD maintenance treatment was based on data from Study KRONOS (NCT02497001). Similarly, the Food and Drug Administration (FDA) approval in the USA was based on data from Study ETHOS (NCT02465567). Both KRONOS and ETHOS were double-blind, randomized, multi-center, parallel-group, chronic-dosing phase 3 trials conducted to evaluate the effectiveness and safety of Breztri Aerosphere. The studies included 10,488 COPD patients with moderate to severe exacerbations who were randomly given either Breztri Aerosphere, dual combination therapies of Bevespi Aerosphere (glyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate), or a placebo.

The primary endpoint of the KRONOS study was the forced expiratory volume in one second (FEV1) area under the curve (AUC0-4), whereas the primary endpoint of the ETHOS study was the rate of moderate or severe COPD exacerbation. The patients were monitored for 24 weeks in the KRONOS trial and 52 weeks in the ETHOS trial.

The results of the trials demonstrated that Breztri Aerosphere significantly improved lung function and reduced the rate of exacerbations in comparison to the dual combination therapies. Specifically, the Breztri Aerosphere patients exhibited a higher FEV1 AUC compared to the alternatives. Moreover, Breztri Aerosphere patients saw a significant reduction in exacerbation frequency over 52 weeks.

The ETHOS and KRONOS studies are a part of AstraZeneca’s ATHENA Phase III clinical trial program for Breztri Aerosphere, which included more than 15,500 patients globally across 11 trials.