Once-daily fluticasone furoate/vilanterol vs once-daily fluticasone furoate in patients with asthma aged 5 to 17 years

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology Pub Date : 2024-11-01 DOI:10.1016/j.anai.2024.06.024

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引用次数: 0

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 1:1 randomization to 24-week 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 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.

查看原文本刊更多论文

5-17岁哮喘患者每日一次糠酸氟替卡松/维兰特罗与每日一次糠酸氟替卡松的对比。

背景：在儿童哮喘患者中，比较吸入性皮质类固醇（ICS）加辅助治疗与单用 ICS 的数据有限：评估糠酸氟替卡松/维兰特罗（FF/VI）与糠酸氟替卡松在儿童和青少年哮喘患者中的疗效和安全性：这项 3 期随机、双盲、多中心研究（NCT03248128）的参与者年龄为 5-17 岁，哮喘病史≥6 个月，接受 ICS 单药治疗后未得到控制。参与者先接受为期 4 周、每天两次的开放标签丙酸氟替卡松（100 µg）治疗，然后按 1:1 随机分配到为期 24 周、每天一次的双盲 FF（50 µg：100 µg）或 FF/VI（50/25 µg：100/25 µg）治疗中。对两个主要终点不同的人群进行了分析，以满足美国（第12周加权平均1秒用力呼气容积[FEV1；0-4小时]；参与者年龄5-17岁）和欧洲（第1-12周平均晨间峰值呼气流量[ΔAM PEF]与基线相比的变化；参与者年龄5-11岁）调节器的要求：共有 902 名参与者接受了随机治疗，其中包括 673 名 5-11 岁的儿童。在 5-17 岁的参与者中，FF/VI 与 FF 相比，第 12 周加权平均 FEV1（0-4 小时）更大（差异：0.083 升；P < .001）。在 5-11 岁的参与者中，第 1-12 周的 ΔAM PEF 显示出 FF/VI 相对于 FF 的数值改善，但无统计学意义（差异：3.2 升/分钟；P = .228）。没有与药物相关的严重不良事件或死亡报告：结论：与 FF 相比，FF/VI 能明显改善加权平均 FEV1（0-4 小时；5-17 岁的参与者），但不能改善 ΔAM PEF（5-11 岁的参与者）。没有发现新的安全问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Allergy Asthma & Immunology 医学-过敏

CiteScore

6.50

自引率

6.80%

发文量

437

审稿时长

33 days

期刊介绍： Annals of Allergy, Asthma & Immunology is a scholarly medical journal published monthly by the American College of Allergy, Asthma & Immunology. The purpose of Annals is to serve as an objective evidence-based forum for the allergy/immunology specialist to keep up to date on current clinical science (both research and practice-based) in the fields of allergy, asthma, and immunology. The emphasis of the journal will be to provide clinical and research information that is readily applicable to both the clinician and the researcher. Each issue of the Annals shall also provide opportunities to participate in accredited continuing medical education activities to enhance overall clinical proficiency.