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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
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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.