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首页> 外文期刊>Respiratory Research >Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study
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Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study

机译：单吸入器糠酸氟替卡松/乌米地林/维兰特罗与氟替卡松糠酸酯/维地洛尔加乌米地林使用两种吸入器治疗慢性阻塞性肺疾病：一项随机性非劣效性研究

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BackgroundSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25?μg has been shown to improve lung function and health status, and reduce exacerbations, versus budesonide/formoterol in patients with chronic obstructive pulmonary disease (COPD). We evaluated the non-inferiority of single-inhaler FF/UMEC/VI versus FF/VI?+?UMEC using two inhalers. MethodsEligible patients with COPD (aged ≥40?years; ≥1 moderate/severe exacerbation in the 12?months before screening) were randomized (1:1; stratified by the number of long-acting bronchodilators [0, 1 or 2] per day during run-in) to receive 24-week FF/UMEC/VI 100/62.5/25?μg and placebo or FF/VI 100/25?μg?+?UMEC 62.5?μg; all treatments/placebo were delivered using the ELLIPTA inhaler once-daily in the morning. Primary endpoint: change from baseline in trough forced expiratory volume in 1?s (FEV1) at Week 24. The non-inferiority margin for the lower 95% confidence limit was set at ??50?mL. ResultsA total of 1055 patients (844 [80%] of whom were enrolled on combination maintenance therapy) were randomized to receive FF/UMEC/VI ( n =?527) or FF/VI?+?UMEC ( n =?528). Mean change from baseline in trough FEV1 at Week 24 was 113?mL (95% CI 91, 135) for FF/UMEC/VI and 95?mL (95% CI 72, 117) for FF/VI?+?UMEC; the between-treatment difference of 18?mL (95% CI -13, 50) confirmed FF/UMEC/VI’s was considered non-inferior to FF/VI?+?UMEC. At Week 24, the proportion of responders based on St George’s Respiratory Questionnaire Total score was 50% (FF/UMEC/VI) and 51% (FF/VI?+?UMEC); the proportion of responders based on the Transitional Dyspnea Index focal score was similar (56% both groups). A similar proportion of patients experienced a moderate/severe exacerbation in the FF/UMEC/VI (24%) and FF/VI?+?UMEC (27%) groups; the hazard ratio for time to first moderate/severe exacerbation with FF/UMEC/VI versus FF/VI?+?UMEC was 0.87 (95% CI 0.68, 1.12). The incidence of adverse events was comparable in both groups (48%); the incidence of serious adverse events was 10% (FF/UMEC/VI) and 11% (FF/VI?+?UMEC). ConclusionsSingle-inhaler triple therapy (FF/UMEC/VI) is non-inferior to two inhalers (FF/VI?+?UMEC) on trough FEV1 change from baseline at 24?weeks. Results were similar on all other measures of efficacy, health-related quality of life, and safety. Trial registrationGSK study CTT200812; ClinicalTrials.gov NCT02729051 (submitted 31 March 2016).
机译：背景与布地奈德/福莫特罗相比，单药吸入剂糠酸氟替卡松/乌米地林/维兰特罗（FF / UMEC / VI）100 / 62.5 /25μg已被证明与布地奈德/福莫特罗相比具有改善肺功能和健康状况并减少病情加重的作用（ COPD）。我们使用两个吸入器评估了单吸入器FF / UMEC / VI与FF /VIα+ΔUMEC的非劣效性。方法将符合条件的COPD患者（年龄≥40岁;筛查前12个月中≥1次中度/重度加重）随机分组（1：1;按每天使用长效支气管扩张剂的数量[0、1或2]进行分层）在磨合期间）接受24周的FF / UMEC / VI 100 / 62.5 / 25？g和安慰剂或FF / VI 100/25？μg？+？UMEC 62.5？g;每天早晨使用ELLIPTA吸入器进行所有治疗/安慰剂。主要终点：在第24周时，以1？s（FEV 1 ）的低谷呼气量相对于基线的变化。下限95％置信水平的非自卑裕度设定为?? 50？mL 。结果总共有1055名患者（其中844名[80％]参加了联合维持治疗）被随机分配接受FF / UMEC / VI（n = 527）或FF / VI + + UMEC（n = 528）。对于FF / UMEC / VI，第24周时谷底FEV 1 相对于基线的平均变化为FF / UMEC / VI为113？mL（95％CI 91，135），对于FF为95？mL（95％CI 72，117） / VI？+？UMEC;治疗之间的差异为18？mL（95％CI -13，50），证实FF / UMEC / VI不亚于FF / VI？+？UMEC。在第24周时，根据圣乔治呼吸问卷调查总得分的回应者比例为50％（FF / UMEC / VI）和51％（FF / VI？+？UMEC）;基于过渡呼吸困难指数重点评分的应答者比例相似（两组均为56％）。 FF / UMEC / VI（24％）和FF ​​/ VI？+？UMEC（27％）组中有类似比例的患者出现中度/重度加重。 FF / UMEC / VI与FF / VI ++ UMEC相比，首次中度/重度加重时间的危险比为0.87（95％CI 0.68，1.12）。两组的不良事件发生率相当（48％）;严重不良事件的发生率为10％（FF / UMEC / VI）和11％（FF / VI？+？UMEC）。结论在24周时，从基线开始的FEV 1 谷值变化，单吸入三联疗法（FF / UMEC / VI）不逊于两个吸入器（FF / VI？+？UMEC）。在功效，与健康相关的生活质量和安全性的所有其他指标上，结果均相似。试用注册GSK研究CTT200812; ClinicalTrials.gov NCT02729051（2016年3月31日提交）。

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