BREZTRI® is the commercial brand name of Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol, a fixed triple combination inhaled therapy consisting of inhaled corticosteroid, long-acting muscarinic antagonist and long-acting β₂ agonist developed by AstraZeneca. It exerts anti-inflammatory and dual bronchodilatory effects to relieve airway inflammation and persistent bronchoconstriction.
Main Indications
Maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in adult patients inadequately controlled by inhaled corticosteroid combined with long-acting β₂ agonist.
Clinical Research
Global multicenter phase III trials demonstrated that this triple fixed combination significantly improves lung function, alleviates dyspnea and lowers the risk of moderate and severe COPD exacerbations versus dual inhaled regimens;
Clinical studies in Asian populations validated consistent therapeutic effects and tolerability;
Long-term observational trials confirmed persistent respiratory symptom control and a manageable safety profile during continuous inhalation treatment.
Common Side Effects
Severe but important risks: Paradoxical bronchospasm, severe hypersensitivity reactions, glaucoma and urinary retention;
Common mild adverse reactions: Nasopharyngitis, oral candidiasis, cough, hoarseness, headache, dry mouth and palpitations.
Approval Status in China
Original drug BREZTRI® (Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol) was officially approved for marketing in China in 2023. It is currently a prescription inhaled medicine for chronic obstructive pulmonary disease.
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