Salbutamol/budesonide
Combination of | |
---|---|
Salbutamol | Beta2-adrenergic agonist |
Budesonide | Corticosteroid |
Clinical data | |
Trade names | Airsupra |
Other names | PT027, albuterol/budesonide |
AHFS/Drugs.com | Monograph |
License data | |
Routes of administration | Inhalation |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Salbutamol/budesonide, sold under the brand name Airsupra, is a fixed-dose combination medication for the treatment of bronchoconstriction and asthma.[1][2] It is a combination of salbutamol sulfate (albuterol sulfate), a short-acting beta2-adrenergic agonist, and budesonide, an inhaled corticosteroid.[1][2] It is inhaled using a pressurized metered-dose inhaler.[1][2]
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]
References
- ^ a b c d e "Archived copy" (PDF). Archived (PDF) from the original on 21 January 2023. Retrieved 20 January 2023.
{{cite web}}
: CS1 maint: archived copy as title (link) - ^ a b c d e f g h i "FDA approves drug combination treatment for adults with asthma". U.S. Food and Drug Administration. 11 January 2023. Archived from the original on 20 January 2023. Retrieved 20 January 2023. This article incorporates text from this source, which is in the public domain.
- ^ "Airsupra (PT027) approved in the US for asthma". AstraZeneca (Press release). 11 January 2023. Archived from the original on 20 January 2023. Retrieved 20 January 2023.
Further reading
- Papi A, Chipps BE, Beasley R, Panettieri RA, Israel E, Cooper M, et al. (June 2022). "Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma". The New England Journal of Medicine. 386 (22): 2071–2083. doi:10.1056/NEJMoa2203163. hdl:11392/2487599. PMID 35569035.
External links
- 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
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