Salbutamol/budesonide

Salbutamol/budesonide
Combination of
SalbutamolBeta2-adrenergic agonist
BudesonideCorticosteroid
Clinical data
Trade namesAirsupra
Other namesPT027, albuterol/budesonide
AHFS/Drugs.comMultum Consumer Information
License data
Routes of
administration		Inhalation
ATC code
  • None
Legal status
Legal status

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

  1. 1 2 3 4 5 "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)
  2. 1 2 3 4 5 6 7 8 9 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ "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

  • 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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