Albuterol-budesonide rescue inhaler for asthma: Patterns of use and safety in the MANDALA trial.

BACKGROUND

The MANDALA study (NCT03769090) in moderate-to-severe asthma served as the basis of the Food and Drug Administration's 2023 approval of albuterol-budesonide 180/160 µg pressurized metered-dose inhaler for the as-needed treatment or prevention of bronchoconstriction and to reduce exacerbation risk in patients with asthma aged 18 years or older. Clinicians would benefit from an understanding of the patterns of use of albuterol-budesonide vs albuterol and overall inhaled corticosteroid (ICS) exposure when ICS-containing rescue therapies are used alongside ICS-based maintenance therapies.

OBJECTIVE

To evaluate patterns of as-needed use and safety profiles of albuterol-budesonide 180/160 µg vs albuterol 180 µg, using data from MANDALA.

METHODS

Study medication use was patient-documented using an electronic diary. Safety was assessed as adverse events. Patterns of study medication use (2 inhalations = 1 dose) were summarized as mean percentages of days in which inhalations per day fell within predefined categories (0, 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, and >12).

RESULTS

The safety population included 981 patients randomized to as-needed albuterol-budesonide and 981 to as-needed albuterol. Patients adhered to maintenance therapy regimens on a mean of more than or equal to 75% of days. Use of as-needed study drug was similar in both groups (mean of 2.6 and 2.8 inhalations/d of albuterol-budesonide and albuterol, respectively). High daily use (≥8 inhalations/d) or long-term high daily use (≥7 consecutive days) was rare. Adverse event frequencies (ICS-associated and not) were low and comparable between groups, regardless of mean daily as-needed use.

CONCLUSION

Patterns of use and safety profiles were similar between as-needed albuterol-budesonide and albuterol.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03769090.