School of Translational Medicine, Manchester Academic Health Science Centre, University of Manchester, UK.
Respir Res. 2011 Oct 6;12(1):132. doi: 10.1186/1465-9921-12-132.
Fluticasone furoate (FF) is a novel long-acting inhaled corticosteroid (ICS). This double-blind, placebo-controlled randomized study evaluated the efficacy and safety of FF 200 mcg or 400 mcg once daily, either in the morning or in the evening, and FF 200 mcg twice daily (morning and evening), for 8 weeks in patients with persistent asthma.
Asthma patients maintained on ICS for ≥ 3 months with baseline morning forced expiratory volume in one second (FEV(1)) 50-80% of predicted normal value and FEV(1) reversibility of ≥ 12% and ≥ 200 ml were eligible. The primary endpoint was mean change from baseline FEV(1) at week 8 in pre-dose (morning or evening [depending on regimen], pre-rescue bronchodilator) FEV(1).
A total of 545 patients received one of five FF treatment groups and 101 patients received placebo (intent-to-treat population). Each of the five FF treatment groups produced a statistically significant improvement in pre-dose FEV(1) compared with placebo (p < 0.05). FF 400 mcg once daily in the evening and FF 200 mcg twice daily produced similar placebo-adjusted improvements in evening pre-dose FEV(1) at week 8 (240 ml vs. 235 ml). FF 400 mcg once daily in the morning, although effective, resulted in a smaller improvement in morning pre-dose FEV(1) than FF 200 mcg twice daily at week 8 (315 ml vs. 202 ml). The incidence of oral candidiasis was low (0-4%) and UC excretion was comparable with placebo for all FF groups.
FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo. FF 400 mcg once daily in the evening had similar efficacy to FF 200 mcg twice daily and all FF regimens had a safety tolerability profile generally similar to placebo. This indicates that inhaled FF is an effective and well tolerated once-daily treatment for mild-to-moderate asthma.
NCT00398645.
糠酸氟替卡松（FF）是一种新型长效吸入性皮质类固醇（ICS）。这项双盲、安慰剂对照随机研究评估了 FF 200 mcg 或 400 mcg 每日一次，无论是在早上还是晚上，以及 FF 200 mcg 每日两次（早晚），在持续哮喘患者中使用 8 周的疗效和安全性。
哮喘患者在基线时维持 ICS 治疗≥3 个月，基础晨时一秒用力呼气容积（FEV1）占预计正常值的 50-80%，FEV1 可逆性≥12%和≥200 ml。主要终点是第 8 周时预剂量（晨或晚上[取决于方案]，预救支气管扩张剂）FEV1 的基线变化的平均值。
共有 545 名患者接受了五种 FF 治疗组中的一种，101 名患者接受了安慰剂（意向治疗人群）。与安慰剂相比，五种 FF 治疗组中的每一种都使预剂量 FEV1 产生了统计学上的显著改善（p<0.05）。晚上服用 FF 400 mcg 每日一次和每日两次服用 FF 200 mcg 产生了类似的晚上预剂量 FEV1 的安慰剂调整改善，在第 8 周时为 240 ml 比 235 ml。虽然有效，但早上服用 FF 400 mcg 每日一次，在第 8 周时对晨时预剂量 FEV1 的改善小于每日两次服用 FF 200 mcg（315 ml 比 202 ml）。口腔念珠菌病的发生率较低（0-4%），所有 FF 组的 UC 排泄与安慰剂相当。
FF 的总日剂量为 200 mcg 或 400 mcg 时，与安慰剂相比显著更有效。晚上服用 FF 400 mcg 每日一次与每日两次服用 FF 200 mcg 具有相似的疗效，所有 FF 方案的安全性耐受性概况与安慰剂相似。这表明吸入 FF 是一种有效且耐受良好的轻度至中度哮喘的每日一次治疗方法。
NCT00398645。
