Clinical Research Institute of Southern Oregon, 3860 Crater Lake Avenue, Medford, OR 97504, USA.
Respir Med. 2013 Apr;107(4):560-9. doi: 10.1016/j.rmed.2012.12.014. Epub 2013 Jan 23.
Fluticasone furoate (FF)/vilanterol (VI) is a novel once-daily inhaled corticosteroid/long-acting β2-agonist combination therapy for COPD. We aimed to assess the efficacy and safety of two strengths of FF/VI (100/25 μg; 50/25 μg) vs. individual components (FF 100 μg, VI 25 μg) and placebo over 24 weeks.
Multicentre, randomised, placebo-controlled, double-blind, parallel-group study of patients (N = 1030) with moderate-to-severe COPD. All medication was administered once daily in the morning. Co-primary efficacy endpoints were: (1) weighted mean (wm) FEV1 (0-4 h post-dose on day 168) to assess acute lung function effects; and (2) trough FEV1 (23-24 h post-dose on day 169) to assess long-lasting effects. Symptom-related outcomes were analysed and adverse events (AEs) assessed.
Main findings were: (1) the combination of FF/VI at a strength of 100/25 μg significantly (p < 0.001) improved wm FEV1 (173 ml) and trough FEV1 (115 ml) vs. placebo. Similar effects were observed with FF/VI 50/25 μg; (2) no significant difference was seen between FF/VI 100/25 μg and VI 25 μg for trough FEV1 (48 ml, p = 0.082), while an effect was observed between FF/VI 100/25 μg and FF 100 μg for wm FEV1 (120 ml, p < 0.001); (3) VI 25 μg over 24 weeks improved lung function vs. placebo significantly for wm FEV1 (103 ml, p < 0.001) and trough FEV1 (67 ml, p = 0.017); and (4) no safety signal was observed.
In subjects with moderate-to-severe COPD, FF/VI 100/25 μg provides rapid and significant sustained bronchodilation at 24 weeks. Lung function is improved to a similar extent with FF/VI 50/25 μg and to a somewhat lesser extent with VI 25 μg. All treatments were well tolerated. GSK study number: HZC112206. ClinicalTrials.gov: NCT01053988.
氟替卡松糠酸酯（FF）/维兰特罗（VI）是一种新型的每日一次吸入性皮质类固醇/长效β2-激动剂联合治疗 COPD 的药物。我们旨在评估两种 FF/VI 剂量（100/25μg；50/25μg）与单一药物成分（FF 100μg，VI 25μg）和安慰剂在 24 周时的疗效和安全性。
多中心、随机、安慰剂对照、双盲、平行组研究纳入了 1030 名中重度 COPD 患者。所有药物均每日清晨一次给药。主要疗效终点为：（1）加权平均（wm）FEV1（第 168 天 0-4 小时）评估急性肺功能效应；（2）谷值 FEV1（第 169 天 23-24 小时）评估长期效应。分析了症状相关结局，并评估了不良事件（AE）。
主要发现为：（1）100/25μg 剂量的 FF/VI 联合治疗显著（p<0.001）改善了 wm FEV1（173ml）和谷值 FEV1（115ml），优于安慰剂。50/25μg 剂量的 FF/VI 也观察到了类似的效果；（2）与 VI 25μg 相比，FF/VI 100/25μg 对谷值 FEV1 无显著差异（48ml，p=0.082），而与 FF 100μg 相比，FF/VI 100/25μg 对 wm FEV1 有显著差异（120ml，p<0.001）；（3）24 周时，VI 25μg 治疗可显著改善肺功能，wm FEV1（103ml，p<0.001）和谷值 FEV1（67ml，p=0.017）均优于安慰剂；（4）未观察到安全性信号。
在中重度 COPD 患者中，FF/VI 100/25μg 在 24 周时可迅速、显著地持续支气管扩张。FF/VI 50/25μg 和 VI 25μg 治疗均可使肺功能改善到相似程度，而 FF/VI 100/25μg 治疗则使肺功能改善程度稍低。所有治疗均具有良好的耐受性。GSK 研究编号：HZC112206。临床试验.gov：NCT01053988。
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