Bareille P, Forth R, Imber V, Bondarenko I, Michaud A, Majorek-Olechowska B. Ann Allergy Asthma Immunol. 2024 Jun 25:S1081-1206(24)00376-4. doi: 10.1016/j.anai.2024.06.024.
Abstract
Background
Limited data exist comparing inhaled corticosteroid (ICS) plus adjunctive therapy versus ICS alone in pediatric asthma patients.
Objective
Evaluate the efficacy and safety of fluticasone furoate/vilanterol (FF/VI) versus FF in children and adolescents with asthma.
Methods
This Phase 3, randomized, double-blind, multicenter study (NCT03248128) included participants aged 5–17 years with ≥6 months’ asthma history uncontrolled on ICS monotherapy. Participants received 4 weeks’ open-label fluticasone propionate (100 µg) twice daily before 1:1 randomization to 24 weeks’ double-blind FF (50 µg:100 µg) or FF/VI (50/25 µg:100/25 µg) once daily. Two populations with different primary endpoints were analyzed to meet United States (Week 12 weighted mean forced expiratory volume in 1 second [FEV1; 0–4 hours]; participants aged 5–17 years) and European (change from baseline pre-dose morning peak expiratory flow [ΔAM PEF] averaged over Weeks 1–12; participants aged 5–11 years) regulator requirements.
Results
Overall, 902 participants were randomized and treated, including 673 children aged 5–11 years. In participants aged 5–17, Week 12 weighted mean FEV1 (0–4 hours) was greater with FF/VI versus FF (difference: 0.083 L; P < .001). In participants aged 5–11, ΔAM PEF over Weeks 1–12 showed numerical improvement with FF/VI versus FF but was not statistically significant (difference: 3.2 L/minute; P = .228). No drug-related serious adverse events or deaths were reported.
Conclusion
FF/VI significantly improved weighted mean FEV1 (0–4 hours; participants aged 5–17 years), but not ΔAM PEF (participants aged 5–11 years) versus FF. No new safety concerns were apparent.