The most common side effects include headache, oral candidiasis, cough, and difficulty speaking.[2]
Salbutamol/budesonide was approved for medical use in the United States in January 2023.[2][3] It is the first combination of an inhaled corticosteroid and a short-acting beta-agonist to be approved by the US Food and Drug Administration (FDA).[2] It is the first product containing an inhaled corticosteroid to be approved by the FDA as a reliever treatment (rather than as a controller) for asthma.[2]
Medical uses
Salbutamol/budesonide is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks.[1][2]
History
The efficacy of salbutamol/budesonide to reduce the risk of severe asthma attacks was evaluated in participants with moderate to severe asthma in MANDALA (NCT03769090), a randomized, double-blind, multicenter study.[2]
Clinical trial number NCT03769090 for "A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma (MANDALA)" at ClinicalTrials.gov