Dual bronchodilation with QVA149 versus single bronchoditator therapy: the SHINE study
Dual bronchodilation with QVA149 versus single bronchoditator therapy: the SHINE study
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DOI：
10.1183/09031936.00200212
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发表时间：
2013-12-01
影响因子：
24.3
通讯作者：
Banerji, Donald
中科院分区：
文献类型：
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作者：
Bateman, Eric D.;Ferguson, Gary T.;Banerji, Donald
我们对中重度慢性阻塞性肺疾病(COPD)患者应用QVA149与其单组分吲达卡特罗、格列普罗铵、硫托品和安慰剂进行双支气管扩张的疗效和安全性进行了研究。这是一项多中心、随机、双盲、安慰剂和积极对照的26周试验。2144例患者按2：2：2：2：1的比例随机接受QVA149(吲达特罗110 mU g/格列普罗铵50 mU g)、吲达卡特罗150 mU g、格列普罗铵50 mU g、开放标签硫托溴铵18 mU g或安慰剂治疗。QVA149的主要终点是26周时的第一秒用力呼气量(FEV1)谷值，QVA149与其单一成分比较。次要终点包括呼吸困难、健康状况、抢救药物使用和安全性。26周FEV1显著改善(p
We investigated the efficacy and safety of dual bronchodilation with QVA149 versus its monocomponents indacaterol and glycopyrronium, tiotropium and placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).This was a multicentre, randomised, double-blind, placebo- and active-controlled, 26-week trial. Patients (n=2144) were randomised (2:2:2:2:1) to receive once-daily QVA149 (indacaterol 110 mu g/glycopyrronium 50 mu g), indacaterol 150 mu g, glycopyrronium 50 mu g, open-label tiotropium 18 mu g or placebo. The primary end-point was trough forced expiratory volume in 1 s (FEV1) at week 26 for QVA149 versus its monocomponents. Secondary end-points included dyspnoea, health status, rescue medication use and safety.Trough FEV1 at week 26 was significantly improved (p