Once-Daily Fluticasone Furoate/Vilanterol Versus Once-Daily Fluticasone Furoate in Asthma Patients Aged 5-17 Years.

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 11 randomization to 24 weeks' double-blind FF (50 µg100 µg) or FF/VI (50/25 µg100/25 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.