Department of Pulmonary Diseases, University Medical Center Groningen, The Netherlands.
Allergy. 2010 Dec;65(12):1531-5. doi: 10.1111/j.1398-9995.2010.02414.x.
Single-dose inhaled corticosteroids (ICS) induce direct anti-inflammatory effects in asthma thereby improving airway hyperresponsiveness (AHR). A novel enhanced-affinity ICS, fluticasone furoate (FF), demonstrated a prolonged duration of action in vitro. The aim of this study was to evaluate the efficacy and duration of action of a single dose of FF by studying protection against AHR to adenosine 5'-monophosphate (AMP) and effects on exhaled nitric oxide (eNO).
A randomized, double-blind, placebo-controlled, 6-way crossover study (FFA10026) was performed in 24 patients with allergic asthma (mean age 32.8 years, FEV(1) ≥ 70% predicted and PC(20) AMP ≤ 50 mg/ml). Each subject received a single dose of FF 1000 μg, fluticasone proprionate (FP) 1000 μg, or placebo at 2 (FF only), 14 or 26 h prior to AMP challenge and eNO measurement.
FF significantly improved PC(20) AMP compared to placebo, the difference in doubling concentrations being 2.18 (95% confidence interval: 1.13-3.23), 1.54 (0.48-2.59), and 1.30 (0.26-2.34) at 2, 14 and 26 h. FP improved PC(20) AMP significantly at 14 h compared to placebo, but not at the 26-hour time point, the difference in doubling concentrations being 1.72 (0.70-2.75) and 0.33 (-0.69-1.34). There was no significant effect on eNO after either FF or FP at all time points. FF was well tolerated and there were no serious adverse events.
The new inhaled corticosteroid FF, but not FP, demonstrates prolonged protection up to 26 h against AHR to AMP in asthma patients.
单剂量吸入皮质类固醇（ICS）可在哮喘中直接发挥抗炎作用，从而改善气道高反应性（AHR）。一种新型高亲和力 ICS，糠酸氟替卡松（FF），在体外表现出更长的作用持续时间。本研究旨在通过研究对单剂量 FF 预防对单磷酸腺苷（AMP）的 AHR 保护作用和对呼出一氧化氮（eNO）的影响来评估其疗效和作用持续时间。
在 24 名过敏性哮喘患者（平均年龄 32.8 岁，FEV（1）≥70%预测值，PC（20）AMP≤50mg/ml）中进行了一项随机、双盲、安慰剂对照、6 向交叉研究（FFA10026）。每个患者在 AMP 挑战和 eNO 测量前 2（仅 FF）、14 或 26 小时接受一次 FF1000μg、丙酸氟替卡松（FP）1000μg 或安慰剂治疗。
FF 与安慰剂相比，显著改善了 PC（20）AMP，差异倍数浓度为 2.18（95%置信区间：1.13-3.23）、1.54（0.48-2.59）和 1.30（0.26-2.34）在 2、14 和 26 小时。FP 在 14 小时与安慰剂相比显著改善了 PC（20）AMP，但在 26 小时时没有差异，差异倍数浓度为 1.72（0.70-2.75）和 0.33（-0.69-1.34）。在所有时间点，FF 或 FP 对 eNO 均无明显影响。FF 耐受性良好，无严重不良事件。
新型吸入皮质类固醇 FF 可在哮喘患者中提供长达 26 小时的 AMP 引起的 AHR 保护作用，而 FP 则没有。
