Department of Medicine, University of Cape Town, , Cape Town, South Africa.
Thorax. 2014 Apr;69(4):312-9. doi: 10.1136/thoraxjnl-2013-203600. Epub 2013 Nov 19.
Combination therapy with an inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) is recommended for patients with asthma symptomatic on ICS alone. However, there is ongoing debate regarding the risk-benefit ratio of using LABA in asthma.
To evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe asthma exacerbations in patients with uncontrolled asthma.
This randomised double-blind comparative study of variable duration (≥ 24-78 weeks) was designed to finish after 330 events (each patient's first on-treatment severe asthma exacerbation). 2019 patients with asthma aged ≥ 12 years with ≥ 1 recorded exacerbation within 1 year were randomised and received FF/VI 100/25 μg or FF 100 μg, administered once daily in the evening. The primary endpoint was time to first severe exacerbation; secondary endpoints were rate of severe asthma exacerbations per patient per year and change in trough evening forced expiratory volume in 1 s (FEV1) from baseline.
Compared with FF, FF/VI delayed the time to first severe exacerbation (HR 0.795, 95% CI 0.642 to 0.985) and reduced the annualised rate of severe exacerbations (rate reduction 25%, 95% CI 5% to 40%). Significantly greater improvements in trough FEV1 (p<0.001) were observed with FF/VI than with FF at weeks 12, 36, 52 and at endpoint. Both treatments were well tolerated with similar rates of treatment-related adverse events and on-treatment serious adverse events.
Once-daily FF/VI reduced the risk of severe asthma exacerbations and improved lung function compared with FF alone, with good tolerability and safety profile in adolescents and adults with asthma currently receiving ICS.
NCT01086384.
对于仅使用吸入性皮质类固醇（ICS）治疗仍有症状的哮喘患者，推荐采用 ICS 与长效β2 激动剂（LABA）联合治疗。然而，目前对于在哮喘中使用 LABA 的风险-获益比仍存在争议。
评估新型 LABA（维兰特罗，VI）联合每日一次 ICS（糠酸氟替卡松，FF）治疗对未控制哮喘患者重度哮喘恶化风险的影响。
这是一项随机、双盲、对照、可变疗程（≥24-78 周）的研究，计划在 330 例事件（每位患者首次治疗的重度哮喘恶化）后结束。共纳入 2019 例年龄≥12 岁、过去 1 年中≥1 次记录的哮喘加重的哮喘患者，按 1:1 随机分组，接受 FF/VI（100/25μg）或 FF（100μg）治疗，每日晚间一次给药。主要终点为首次重度恶化时间；次要终点为患者每年重度哮喘恶化率和从基线到夜间谷值用力呼气量（FEV1）的变化。
与 FF 相比，FF/VI 延迟了首次重度恶化的时间（风险比 0.795，95%置信区间 0.642 至 0.985），降低了重度恶化的年化发生率（发生率降低 25%，95%置信区间 5%至 40%）。FF/VI 组较 FF 组在第 12、36、52 周和终点时，夜间谷值 FEV1 改善更显著（p<0.001）。两种治疗方案均具有良好的耐受性，治疗相关不良事件和治疗期间严重不良事件的发生率相似。
与单独使用 FF 相比，每日一次 FF/VI 可降低重度哮喘恶化的风险，并改善肺功能，在目前接受 ICS 治疗的青少年和成人哮喘患者中具有良好的耐受性和安全性。
临床试验.gov 注册号：NCT01086384。
