Methods: This phase 3, double-blind, parallel-group, 3-week study (ABS-AS-303; NCT02126839) included children (aged 4─11 years) with asthma and prestudy FEV1 of 50%–95% of predicted. After a 14-day run-in period during which patients continued their current asthma therapy and received single-blind placebo MDPI, patients were randomized to albuterol MDPI, 90 mcg/inhalation, 2 inhalations 4 times daily (total daily dose, 720 mcg) or placebo for 3 weeks. Pulmonary function testing occurred at clinic visits on days 1 and 22. Efficacy and safety were evaluated by measuring area under the baseline-adjusted percent predicted FEV1 time curve over 6 hours postdose (PPFEV1 AUC0-6) and adverse events.
Results: The full analysis set included 184 patients. Albuterol MDPI–treated patients experienced significantly (P<0.0001) greater improvements in PPFEV1 AUC0-6 over the 3-week study versus placebo recipients (least squares mean difference of 25%•h in favor of albuterol). The benefit of albuterol (mean change in PPFEV1) was evident 5 minutes after dosing and lasted several hours; maximal effect was noted 1–2 hours postdose. Albuterol MDPI was well tolerated.
Conclusions: Albuterol MDPI, administered chronically for 3 weeks, improved pulmonary function in pediatric patients significantly better than placebo. Clinical effects were evident within 5 minutes after dosing and were maintained for >2 hours. Four-times-daily administration was generally well tolerated in pediatric patients.