Fixed-Dose Combo Airsupra Approved as Rescue Therapy for Asthma

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.

This article originally appeared on MPR