Once-daily indacaterol acetate shows promise in pediatric asthma
The combination of indacaterol acetate (IND) and mometasone furoate (MF) as a once-daily treatment shows significant promise for pediatric patients between 6 and 12 years of age with persistent asthma, according to results of a Phase 2b study that demonstrated both doses of IND (75 µg and 150 µg) led to notable improvements in lung function and asthma control compared to baseline measurements.
In this multicenter, randomized, double-blind, parallel-group trial, 80 patients were enrolled and randomly assigned to receive either IND 75 µg or IND 150 µg once daily via Breezhaler, in conjunction with standard inhaled corticosteroid (ICS) background therapy. The primary objective was to measure the change from baseline in pre-dose trough forced expiratory volume in one second (FEV1) after 2 weeks of treatment.
Results demonstrated a positive outcome, with both IND doses exhibiting improvements in pre-dose trough FEV1 compared to baseline measurements on Day 14. Specifically, the IND 75 µg group showed a mean change of 212 mL, while the IND 150 µg group demonstrated a change of 171 mL. Secondary spirometry parameters, including post-dose FEV1 after 1 hour and post-dose forced vital capacity, as well as morning and evening peak expiratory flow, also displayed notable enhancement.
A significant proportion of patients exhibited enhanced control over their asthma symptoms. Approximately 36.1% of those in the IND 75 µg group and 25% in the IND 150 µg group achieved a reduction of ≥ 0.5 units in their Pediatric Interviewer-administered Asthma Control Questionnaire score compared to baseline.
A dose-dependent increase in plasma IND concentration was observed between the two groups. Both IND doses demonstrated an acceptable safety profile, assuring the treatment’s viability in pediatric patients.
Sekerel BE, Nell H, Laki I, et al. Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study. Clin Drug Investig. 2023;43(9):719-728. doi: 10.1007/s40261-023-01300-8. Epub 2023 Sep 8. PMID: 37682405; PMCID: PMC10514176.