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首页> 外文期刊>Allergy >Once-daily fluticasone furoate 50 mcg in mild-to-moderate asthma: A 24-week placebo-controlled randomized trial
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Once-daily fluticasone furoate 50 mcg in mild-to-moderate asthma: A 24-week placebo-controlled randomized trial

机译：每日日常氟替辛源于50mcg，温和至中等哮喘：一个24周的安慰剂对照随机试验

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摘要

Background Inhaled glucocorticosteroids (ICS) are the mainstay of treatment in asthma. Fluticasone furoate (FF) is a novel, once-daily ICS asthma therapy. This study investigated the efficacy and safety of FF 50 mcg in patients with mild-to-moderate persistent asthma.Results Evening trough FEV1 at Week 24 was not statistically significantly increased with FF 50 mcg once-daily (37 ml [95% CI: -55, 128]; P = 0.430), but was with FP 100 mcg twice daily (102 ml [10, 194]; P = 0.030), vs placebo. No consistent trends were observed across other endpoints, including the powered secondary endpoint. No safety concerns were raised for either active treatment.Conclusions FP 100 mcg twice daily improved evening trough FEV1 in patients with mild-to-moderate persistent asthma, but FF 50 mcg once daily did not demonstrate a significant effect. Secondary endpoints showed variable results. No safety concerns were identified for FF or FP.Methods A 24-week, multicenter, randomized, placebo-controlled and active-controlled, double-blind, double-dummy, parallel-group phase III study. Three hundred and fifty-one patients (aged ≥12 years; uncontrolled by non-ICS therapy) were randomized to treatment (1: 1: 1) with once-daily FF 50 mcg dosed in the evening, twice-daily fluticasone propionate (FP) 100 mcg or placebo. The primary endpoint was change from baseline in evening trough forced expiratory volume in 1 s (FEV1) at Week 24. Secondary endpoints were change from baseline in the percentage of rescue-free 24-h periods (powered endpoint), change from baseline in evening and morning peak expiratory flow, change from baseline in the percentage of symptom-free 24-h periods and number of withdrawals due to lack of efficacy.
机译：背景吸入的糖皮质激素（IC）是哮喘治疗的主要效果。氟辛酮呋喃（FF）是一种新颖的，每日一次ICS哮喘疗法。本研究调查了FF 50mcg对患有轻度至中度持久性哮喘患者的疗效和安全性。结果晚间槽FEV1在第24周的情况下没有统计学显着增加，每日FF 50 mcg（37ml [95％CI： - 55,128]; p = 0.430），但每天两次用FP 100 mcg（102ml [10,194]; p = 0.030），Vs安慰剂。在其他端点上没有观察到一致的趋势，包括供电的辅助端点。无论是活性治疗都没有提高安全问题。结论FP 100 MCG每天两次改进晚间槽FEV1患者轻度至中度持久性哮喘，但每日50毫克每天都没有表现出显着效果。辅助端点显示可变结果。没有为FF或FP确定安全问题。方法24周，多中心，随机，安慰剂控制和主动控制，双盲，双伪，并行组III研究。三百五十一名患者（年龄≥12岁;非ICS治疗的不受控制）被随机进行治疗（1：1：1），每日每日FF 50 MCG，两次给药，每日两次氟丙酮（FP） ）100 mcg或安慰剂。主要终点是在第24周的24小时内从夜间槽强制呼气量的基线发生变化。次级端点是从抢救的24-H周期（Powered Endpoint）的百分比中从基线发生变化，晚上从基线变为基线早上峰值呼气流动，从基线变为无症状24-H周期的百分比和由于缺乏疗效而提取。

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  • 来源
    《Allergy》 |2014年第11期|共9页
  • 作者

    BusseW.W.; BatemanE.D.; OByrneP.M.; L?tvallJ.; WoodcockA.; MedleyH.; ForthR.; JacquesL.;

  • 作者单位

    Department of Medicine University of Wisconsin K4/910 CSC 600 Highland AvenueMadison WI;

    Department of Medicine University of Cape TownCape Town South Africa;

    Michael G DeGroote School of MedicineHamilton ON Canada;

    Krefting Research Centre University of GothenburgGothenburg Sweden;

    Institute of Inflammation and Repair University of ManchesterManchester United Kingdom;

    Respiratory Medicines Development Centre GlaxoSmithKlineLondon United Kingdom;

    Quantitative Sciences Division GlaxoSmithKlineResearch Triangle Park NC United States;

    Respiratory Medicines Development Centre GlaxoSmithKlineLondon United Kingdom;

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  • 正文语种 eng
  • 中图分类 医学免疫学;
  • 关键词

    fluticasone furoate; fluticasone propionate; inhaled corticosteroid; lung function; safety;

    机译：氟替辛;氟替卡松丙酸盐;吸入皮质类固醇;肺功能;安全;

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