A new treatment for chronic obstructive pulmonary disease (COPD) is now available in the United States, Europe, China, and Japan, offering a single-inhaler combination of three medications. BREZTRI AEROSPHERE, marketed as TRIXEO AEROSPHERE in the European Union, combines budesonide, glycopyrronium bromide, and formoterol fumarate, and is intended for the maintenance treatment of COPD, according to AstraZeneca, the pharmaceutical company behind the drug.
The medication delivers a fixed dose of the three active ingredients via a pressurized metered-dose inhaler. Budesonide is an inhaled corticosteroid, glycopyrronium bromide is a long-acting muscarinic antagonist (LAMA), and formoterol fumarate is a long-acting beta2-adrenergic agonist (LABA). AstraZeneca states that BREZTRI/TRIXEO Aerosphere is approved in more than 80 countries and was prescribed to over 5.5 million patients globally in 2024.
Clinical trials, including the KALOS and LOGOS Phase III trials, have evaluated the efficacy and safety of BREZTRI Aerosphere compared to other dual-combination therapies. The trials, involving approximately 4,300 patients, assessed changes in forced expiratory volume in one second (FEV1) to measure lung function. Additional qualifying trials, LITHOS and VATHOS, likewise met their primary endpoints.
However, BREZTRI AEROSPHERE is not without its risks and limitations. The drug is contraindicated for patients with a hypersensitivity to any of its components. It is specifically not indicated for the relief of acute bronchospasm or for the treatment of asthma, and should not be used as a rescue inhaler. Excessive use, or use in combination with other LABA-containing medications, carries a risk of overdose and potential cardiovascular complications.
Patients should rinse their mouths with water after each inhalation to reduce the risk of oropharyngeal candidiasis (thrush). Physicians should be vigilant for signs of lower respiratory tract infections, including pneumonia, as symptoms can overlap with COPD exacerbations. The drug’s prescribing information also cautions about potential immunosuppression and the possibility of worsening infections, particularly chickenpox or measles in susceptible individuals.
Careful monitoring is advised for patients transitioning from systemic corticosteroids, as adrenal insufficiency is a potential risk. The drug may also exacerbate certain pre-existing conditions, including cardiovascular disorders, glaucoma, urinary retention, convulsive disorders, and diabetes. AstraZeneca advises caution when co-administering BREZTRI with monoamine oxidase inhibitors, tricyclic antidepressants, strong CYP3A4 inhibitors, adrenergic drugs, xanthine derivatives, beta-blockers, and other anticholinergic-containing drugs.
Common adverse reactions reported in clinical trials included upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea. Dysphonia and muscle spasms were also frequently reported.
AstraZeneca has not yet responded to inquiries regarding potential pricing or patient assistance programs for BREZTRI AEROSPHERE.
