Background To evaluate the effects of fluticasone furoate on the hypothalamic-pituitary-adrenocortical axis, and the safety and tolerability of fluticasone furoate treatment in children with asthma. Methods This was a randomized, double-blind, placebo-controlled, multicenter, stratified, parallel-group, non-inferiority study of fluticasone furoate 50 µg inhalation powder administered once daily. The study enrolled children (aged 5-11 years inclusive) with a documented diagnosis of asthma for ≥ 6 months and a Childhood Asthma Control Test score of > 19. After a 7-14-day run-in period, eligible subjects were stratified by age and randomized to fluticasone furoate 50 µg once daily or placebo once daily via ELLIPTA for 6 weeks. The primary endpoint was the change from baseline (expressed as a ratio) in 0-24-h weighted mean serum cortisol at the end of the treatment period. Results Fifty-six randomized subjects received fluticasone furoate 50 µg once daily and 55 received placebo. The primary analysis was performed in the serum cortisol population (n = 104) and demonstrated that fluticasone furoate 50 µg once daily was non-inferior to placebo (ratio = 0.93; 95% confidence interval 0.8096, 1.0620), as the lower limit of the 95% confidence interval for the geometric mean treatment ratio of fluticasone furoate 50 µg once daily versus placebo was greater than 0.80. Findings from the intent-to-treat population (n = 111) were similar. Conclusions Six weeks of treatment with inhaled fluticasone furoate 50 µg once daily had no clinically relevant effect on the hypothalamic-pituitary-adrenocortical axis function of children, as measured by 24-h serum cortisol profiles. The primary analysis showed that fluticasone furoate 50 µg once daily was non-inferior to placebo. Fluticasone furoate 50 µg once daily was well tolerated and no new safety concerns emerged during the study. Trial registration This study is registered in ClinicalTrials.gov (NCT02483975). Date of submission: 25 June 2015.

中文翻译：

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每日一次吸入糠酸氟替卡松对哮喘儿童下丘脑-垂体-肾上腺皮质轴的随机、双盲、安慰剂对照、平行组研究。

背景 评估糠酸氟替卡松对下丘脑-垂体-肾上腺皮质轴的影响，以及糠酸氟替卡松治疗哮喘儿童的安全性和耐受性。方法 这是一项随机、双盲、安慰剂对照、多中心、分层、平行组、非劣效性的糠酸氟替卡松 50 µg 吸入粉剂，每天给药一次。该研究招募了有记录的哮喘诊断≥ 6 个月且儿童哮喘控制测试得分 > 19 的儿童（包括 5-11 岁）。经过 7-14 天的磨合期后，符合条件的受试者按以下方式分层年龄并通过 ELLIPTA 随机分配到糠酸氟替卡松 50 µg 每天一次或安慰剂每天一次，持续 6 周。主要终点是治疗期结束时 0-24 小时加权平均血清皮质醇相对于基线的变化（以比率表示）。结果 56 名随机受试者接受糠酸氟替卡松 50 µg 每日一次，55 名接受安慰剂。在血清皮质醇人群 (n = 104) 中进行了初步分析，结果表明糠酸氟替卡松 50 µg 每天一次不劣于安慰剂（比率 = 0.93；95% 置信区间 0.8096, 1.0620），作为下限糠酸氟替卡松 50 µg 每天一次与安慰剂的几何平均治疗比率的 95% 置信区间大于 0.80。意向治疗人群（n = 111）的结果相似。结论 6 周吸入糠酸氟替卡松 50 µg 每天一次对儿童的下丘脑-垂体-肾上腺皮质轴功能没有临床相关影响，通过 24 小时血清皮质醇曲线测量。初步分析表明，糠酸氟替卡松 50 µg 每天一次并不劣于安慰剂。糠酸氟替卡松 50 µg 每天一次的耐受性良好，并且在研究期间没有出现新的安全问题。试验注册 本研究已在 ClinicalTrials.gov (NCT02483975) 上注册。提交日期：2015 年 6 月 25 日。糠酸氟替卡松 50 µg 每天一次的耐受性良好，并且在研究期间没有出现新的安全问题。试验注册 本研究已在 ClinicalTrials.gov (NCT02483975) 上注册。提交日期：2015 年 6 月 25 日。糠酸氟替卡松 50 µg 每天一次的耐受性良好，并且在研究期间没有出现新的安全问题。试验注册 本研究已在 ClinicalTrials.gov (NCT02483975) 上注册。提交日期：2015 年 6 月 25 日。