| Combination of | |
|---|---|
| Budesonide | Inhaled corticosteroid |
| Glycopyrronium bromide | Anticholinergicmuscarinic antagonist |
| Formoterol | Long-acting β2 agonist |
| Clinical data | |
| Trade names | Breztri Aerosphere, Trixeo Aerosphere, Riltrava Aerosphere |
| Other names | Budesonide/glycopyrrolate/formoterol fumarate |
| AHFS/Drugs.com | Professional Drug Facts |
| License data | |
| Routes of administration | By mouth (inhalation) |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| KEGG | |
Budesonide/glycopyrronium bromide/formoterol, sold under the brand nameBreztri Aerosphere among others, is an inhalable fixed-dosecombination medication for the treatment ofchronic obstructive pulmonary disease (COPD).[5][6][7] It containsbudesonide,glycopyrronium bromide, andformoterol fumarate dihydrate.[5][6][7] It isinhaled.[5][6][7]
The most common side effects includeoral candidiasis (a fungal infection of the mouth),upper respiratory tract infection,pneumonia, back pain, muscle spasms, influenza,urinary tract infection, cough, sinusitis, anddiarrhea.[5] Headache is also a common side effect.[6][7]
The combination was approved for medical use in the United States in July 2020,[8][9] and in the European Union in December 2020.[6]
Budesonide/glycopyrronium bromide/formoterol isindicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.[5][6][7]
Trixeo Aerosphere was authorized for medical use in the European Union in December 2020.[6] Riltrava Aerosphere was authorized for medical use in the European Union in January 2022.[7]
In 2025, a new budesonide/glycopyrronium bromide/formoterol inhaler using the propellantHFO-1234ze(E) was approved in the United Kingdom, for the treatment ofCOPD.[10]
In July 2025, theEuropean Medicines Agency recommended a change in the composition of Trixeo Aerosphere and its duplicate product Riltrava Aerosphere to replace the existing gas propellant with a low global warming potential gas alternative.[11] The low global warming potential alternative propellant has a 1000-fold reduction in global warming potential and similar physical properties.[11]
