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 ≥18 years of age. Clinicians would benefit from an understanding of the patterns of use of albuterol-budesonide versus albuterol and overall inhaled corticosteroid (ICS) exposure when ICS-containing rescue therapies are utilized alongside ICS-based maintenance therapies.

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

Methods: Study medication use was patient-documented via electronic diary. Safety was assessed as adverse events (AEs). Patterns of study medication use (2 inhalations = 1 dose) were summarized as mean percentages of days where inhalations/day fell within pre-defined categories (0, 1-2, 3-4, 5-6, 7-8, 9-10, 11-12, >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 ≥75% of days. Use of as-needed study drug was similar in both groups (mean of 2.6 and 2.8 inhalations/day of albuterol-budesonide and albuterol, respectively). High daily use (≥8 inhalations/day) or long-term high-daily use (≥7 consecutive days) was rare. AE 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.