Until now, short-acting [beta]2-adrenergic agonist inhalers have been used as "rescue" drugs for the treatment of acute bronchoconstriction in asthma, and inhaled corticosteroids have been used as "maintenance" drugs to prevent asthma attacks. Now the Food and Drug Administration has approved an inhaler that combines both treatment and prevention. Airsupra combines albuterol (a short-acting [beta]2-adrenergic agonist) and budesonide (a corticosteroid) for the treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in people ages 18 years and older.
The efficacy of albuterol-budesonide was shown in two clinical trials: the randomized, double-blind, multicenter MANDALA study and the double-blind, active-comparator, placebo-controlled DENALI study. Although both trials included patients between the ages of 12 and 17, the combination drug is not approved for this age group and its labeling does not include efficacy data for pediatric patients. MANDALA included 2,940 adults who received either the combination of 180 mcg albuterol and 160 mcg budesonide or 180 mcg albuterol alone. All patients continued their regular maintenance therapy during the trial. Those who received the albuterol-budesonide combination experienced a statistically significant 28% reduction in the risk of a severe asthma exacerbation. In the DENALI trial, 964 adults received either albuterol-budesonide 180 mcg/160 mcg or 180 mcg/80 mcg, budesonide 160 mcg, albuterol 180 mcg, or placebo four times a day. The onset of bronchodilation after the 180 mcg/160 mcg albuterol-budesonide dose was faster than it was for albuterol alone (7.5 minutes versus 10 minutes). The duration of bronchodilation was also longer for the 180 mcg/160 mcg combination than for albuterol alone (186.9 minutes versus 167.9 minutes).
Adverse effects of the albuterol-budesonide combination are similar to those of either drug component alone. Albuterol and other [beta]2-adrenergic agonists can induce paradoxical bronchospasm or cardiovascular effects, such as tachycardia and elevated blood pressure. Large or excessive doses can cause excessive sympathetic stimulation. [beta]2-adrenergic agonists can also produce significant hypokalemia in some patients, although this is usually transient. Budesonide, like other corticosteroids, can cause immunosuppression; increased risk of infections; oropharyngeal candidiasis; hypercorticism and adrenal suppression; reduction in bone mineral density; and glaucoma, increased intraocular pressure, and cataracts. The most common adverse effects of the combination inhaler are headache, oral candidiasis, cough, and difficulty speaking.
Nurses and NPs should teach patients how to properly use an inhaler and to take this combination as two inhalations (for a total of 180 mcg of albuterol and 160 mcg of budesonide) as needed for asthma symptoms but not more than 12 inhalations (or six doses) in a 24-hour period. Before using the inhaler for the first time, it must be primed by releasing four sprays into the air, shaking well before each spray. If it has been more than seven days since last used, or if the inhaler was dropped or cleaned, it must be primed again, but this time only two sprays are needed. The nurse or NP should confirm that the patient understands not to stop maintenance therapy when starting this new combination inhaler.
For complete prescribing information for Airsupra, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214070s000lbl.pdf.