The Food and Drug Administration (FDA) has approved Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients 18 years of age and older with asthma.
Airsupra is a pressurized metered dose inhaler containing a combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS). The approval was based on efficacy results in adult patients from two phase 3 trials.
The MANDALA (ClinicalTrials.gov Identifier: NCT03847896) trial included 2940 adults with moderate to severe asthma who were randomly assigned to receive at least 1 dose of Airsupra 180mcg/160mcg, albuterol/budesonide 180mcg/80mcg, or albuterol 180mcg, in addition to their maintenance therapy. The primary endpoint was the time to first severe asthma exacerbation.
Compared with albuterol, patients treated with Airsupra experienced a statistically significant 28% reduction (hazard ratio, 0.72; 95% CI, 0.60-0.86) in the risk of a severe asthma exacerbation (P <.001). Risk reduction was observed regardless of exacerbation history, baseline lung function, and asthma severity. Treatment with Airsupra was also associated with a statistically significant reduction in the annual rate of severe asthma exacerbations compared albuterol (rate ratio, 0.76; 95% CI, 0.62-0.93; P =.008).
In the DENALI trial (ClinicalTrials.gov Identifier: NCT03847896), the efficacy of Airsupra on lung function was evaluated. Patients with mild to moderate asthma who were previously treated with as-needed SABA alone or with low-dose ICS maintenance therapy plus as-needed SABA were randomly assigned to receive Airsupra 180mcg/160mcg, albuterol/budesonide 180mcg/80mcg, budesonide 160mcg, albuterol 180mcg, or placebo. Treatment was administered 4 times daily.
Compared with its individual components and placebo, Airsupra administration resulted in a statistically significant improvement in lung function as measured by forced expiratory volume in 1 second (FEV1). The median time to onset and mean duration of bronchodilation were 7.5 and 186.9 minutes with Airsupra and 10.0 and 167.9 minutes with albuterol, respectively.
Airsupra is supplied as a 120-inhalation metered dose inhaler; each inhalation contains 90mcg/80mcg of albuterol/budesonide.
- Airsupra (PT027) approved in the US for asthma. News release. AstraZeneca. Accessed January 11, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html.
- Airsupra. Package insert. AstraZeneca; 2022. Accessed January 11, 2023. https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/fe598cda-d255-4446-998e-617607f61552/fe598cda-d255-4446-998e-617607f61552_viewable_rendition__v.pdf.