Once-daily fluticasone furoate/vilanterol vs once-daily fluticasone furoate in patients with asthma aged 5 to 17 years.
Ann Allergy Asthma Immunol
; 2024 Jun 25.
Article
em En
| MEDLINE
| ID: mdl-38936466
ABSTRACT
BACKGROUND:
Limited data exist comparing inhaled corticosteroid (ICS) plus adjunctive therapy vs ICS alone in pediatric asthma patients.OBJECTIVE:
To evaluate the efficacy and safety of fluticasone furoate/vilanterol (FF/VI) vs FF in children and adolescents with asthma.METHODS:
This phase 3, randomized, double-blind, multicenter study (NCT03248128) included participants aged 5 to 17 years with six months or more asthma history uncontrolled on ICS monotherapy. Participants received 4-week open-label fluticasone propionate (100 µg) twice daily before 11 randomization to 24-week 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 predose morning peak expiratory flow [ΔAM PEF] averaged over weeks 1-12; participants aged 5-11 years) regulatory requirements.RESULTS:
Overall, 902 participants, including 673 children aged 5 to 11 years, were randomized and treated. In participants aged 5 to 17, week 12 weighted mean FEV1 (0-4 hours) was greater with FF/VI vs FF (difference 0.083 L; P < .001). In participants aged 5 to 11, ΔAM PEF over weeks 1 to 12 showed numerical improvement with FF/VI vs FF but was not statistically significant (difference 3.2 L/min; 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) vs FF. No new safety concerns were apparent. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03248128.
Texto completo:
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Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Ann Allergy Asthma Immunol
/
Ann. allergy asthma immunol
/
Annals of allergy, asthma and immunology
Assunto da revista:
ALERGIA E IMUNOLOGIA
Ano de publicação:
2024
Tipo de documento:
Article