Medical Center for Allergic and Immune Diseases, Yokohama City Minato Red Cross Hospital, Yokohama, Japan.
Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan.
Curr Med Res Opin. 2021 Sep;37(9):1657-1665. doi: 10.1080/03007995.2021.1944849. Epub 2021 Jul 14.
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.
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.
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.
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.
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。
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。
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。
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。
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