Methods: A phase 2, multicenter, double-blind, double-dummy, single-dose, 5-period, crossover study (ABS-AS-202; NCT01899144) randomized pediatric patients (aged 4–11 years) with persistent asthma and prestudy FEV1 of 60%–90% of predicted normal to 1 of 10 treatment sequences containing albuterol MDPI (90 and 180 mcg), albuterol HFA (90 and 180 mcg), and placebo MDPI+placebo HFA. Efficacy was evaluated by measuring area under the baseline-adjusted percent-predicted FEV1-time curve over 6 hours postdose (PPFEV1AUC0-6), and safety was evaluated by adverse events.
Results: The full analysis set included 61 patients. Albuterol MDPI and albuterol HFA significantly improved PPFEV1AUC0-6 vs placebo (P≤0.0107). Improvement in PPFEV1AUC0-6 vs placebo with albuterol MDPI at 90 and 180 mcg was similar (21.2±4.87 [95%CI 11.60,30.81] and 22.6±4.87 [95%CI 13.00,32.20, %•hour, respectively). Improvement with albuterol HFA 180 mcg was significantly [P=0.0226] greater vs albuterol HFA 90 mcg (23.7±4.85 [95%CI 14.13,33.23] and 12.5±4.85 [95%CI 2.93,22.05] %•hour, respectively). All doses of albuterol were generally well tolerated.
Conclusions: Albuterol MDPI significantly improved pulmonary function vs placebo in children with asthma. Improvements for albuterol MDPI 90 and 180 mcg were similar; a dose-response effect was observed with albuterol HFA. Results suggest that relief of asthma symptoms in children may be managed adequately with albuterol MDPI (1–2 inhalations). No new safety concerns were noted with albuterol MDPI, and its safety profile is consistent with that of albuterol HFA.