在未得到充分控制的哮喘日本患者中，每日一次、单吸入器糠酸氟替卡松/乌美溴铵/维兰特罗与糠酸氟替卡松/维兰特罗的疗效和安全性：CAPTAIN 研究。
Efficacy and safety of once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study.
机构信息
Medical Center for Allergic and Immune Diseases, Yokohama City Minato Red Cross Hospital, Yokohama, Japan.
Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan.
出版信息
Curr Med Res Opin. 2021 Sep;37(9):1657-1665. doi: 10.1080/03007995.2021.1944849. Epub 2021 Jul 14.
OBJECTIVE
In CAPTAIN, a double-blind, parallel-group, Phase IIIA study, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) improved lung function, symptoms and asthma control versus FF/VI in patients with inadequately controlled asthma. Here, we report efficacy and safety from a Japanese cohort in CAPTAIN.
METHODS
Adults with inadequately controlled asthma despite inhaled corticosteroid/long-acting β-agonist (ICS/LABA) were randomized (1:1:1:1:1:1) to once-daily FF/VI (100/25 mcg or 200/25 mcg) or FF/UMEC/VI (100/31.25/25 mcg, 100/62.5/25 mcg, 200/31.25/25 mcg, or 200/62.5/25 mcg) for ≥24 weeks. Endpoints included change from baseline in clinic trough FEV (primary), annualized rate of moderate/severe asthma exacerbations (key secondary), clinic FEV 3 h post-dose, and Asthma Control Questionnaire (ACQ)-7, St George's Respiratory Questionnaire (SGRQ) (all Week 24), Evaluating Respiratory Symptoms (E-RS): Asthma total scores (Weeks 21-24) (all secondary). Adverse events and adverse events of special interest were monitored. Clinical trials.gov registry no: NCT02924688.
RESULTS
Overall, 229 of 2436 patients in the intention-to-treat (ITT) population were from Japan. In this cohort, change from baseline in trough FEV for FF/UMEC/VI 100/62.5/25 mcg versus FF/VI 100/25 mcg was 105 mL (95% confidence interval -5, 216) and 69 mL (-42, 179) for 200/62.5/25 mcg versus 200/25 mcg. These observations were supported by clinic FEV at 3 h post-dose. Moderate/severe exacerbation incidence was low and similar across pooled treatment groups (FF/VI, FF/UMEC 31.25 mcg/VI, FF/UMEC 62.5 mcg/VI). All pooled groups demonstrated clinically important improvements from baseline in ACQ-7, SGRQ and E-RS: Asthma total scores. Safety profiles were consistent with the overall ITT population, with no new safety concerns.
CONCLUSION
FF/UMEC/VI is an effective option with a favorable risk-benefit profile in Japanese patients with uncontrolled moderate or severe asthma on ICS/LABA.
目的
在 CAPTAIN 中，一项双盲、平行分组的 IIIA 期研究表明，氟替卡松糠酸酯/乌美溴铵/维兰特罗（FF/UMEC/VI）在未得到充分控制的哮喘患者中，与 FF/VI 相比，改善了肺功能、症状和哮喘控制。在此，我们报告 CAPTAIN 中来自日本队列的疗效和安全性数据。
方法
尽管使用了吸入皮质类固醇/长效β激动剂（ICS/LABA），但仍未得到充分控制的哮喘患者被随机分配（1:1:1:1:1:1）接受每日一次 FF/VI（100/25 mcg 或 200/25 mcg）或 FF/UMEC/VI（100/31.25/25 mcg、100/62.5/25 mcg、200/31.25/25 mcg 或 200/62.5/25 mcg）治疗，持续≥24 周。主要终点为基线时的临床谷值 FEV 变化（主要终点）、每年中度/重度哮喘加重的发生率（关键次要终点）、给药后 3 小时的临床 FEV 和哮喘控制问卷（ACQ）-7、圣乔治呼吸问卷（SGRQ）（所有 24 周）、评估呼吸症状（E-RS）：哮喘总分（21-24 周）（所有次要终点）。监测不良事件和特别关注的不良事件。临床试验.gov 注册号：NCT02924688。
结果
总体而言，意向治疗（ITT）人群中 2436 名患者中有 229 名来自日本。在该队列中，FF/UMEC/VI 100/62.5/25 mcg 与 FF/VI 100/25 mcg 相比，FEV 谷值的变化为 105 mL（95%置信区间为-5，216），FF/UMEC/VI 200/62.5/25 mcg 与 FF/VI 200/25 mcg 相比为 69 mL（-42，179）。这些观察结果得到了给药后 3 小时的临床 FEV 支持。中度/重度加重的发生率在各组间相似，均较低。所有治疗组均表现出从基线开始 ACQ-7、SGRQ 和 E-RS：哮喘总分的临床重要改善。安全性概况与总体 ITT 人群一致，无新的安全性问题。
结论
在 ICS/LABA 治疗未得到充分控制的中重度哮喘的日本患者中，FF/UMEC/VI 是一种有效且具有良好风险效益比的选择。
Zotero 插件