Lin Jiangtao, Chen Ping, Liu Chuntao, Kang Jian, Xiao Wei, Chen Zhengxian, Tang Huaping, Du Xin, Liu Cindy, Luo Linda
China-Japan Friendship Hospital, Beijing 100029, China.
General Hospital of Shenyang Military Region, Shenyang 110000, China.
J Thorac Dis. 2017 Feb;9(2):372-385. doi: 10.21037/jtd.2017.02.51.
This study compared the efficacy and safety of fluticasone propionate (FP) inhalation n solution with budesonide (BUD) suspension for inhalation administered via nebulizer, in Chinese adult patients with severe, persistent asthma.
This was a multicenter, randomized, active-controlled, single-blind, parallel-group study, conducted at 26 clinical sites in China. Participants were randomized 1:1 to FP nebules 1 mg twice daily or BUD 2 mg twice daily via nebulizer for 12 weeks.
A total of 317 adult patients were randomized. The primary endpoint was mean change in morning peak expiratory flow (PEF) over weeks 1-12 from baseline, and analyzed in the ITT (n=315) and PP populations (n=283). Week 12 PEF increase from baseline was 26.7 L/min (14.1%) and 28.0 L/min (15.3%) in the ITT population, and 29.1 L/min (15.7%) and 30.1 L/min (16.2%) in the PP population, in the FP and BUD groups, respectively; all improvements were of clinical significance. Lower limits of the two-sided 95% CIs for the least squares (LS) mean treatment difference (FP minus BUD) were -12.19 L/min (ITT) and -12.95 L/min (PP), both above the pre-specified non-inferiority criteria -12.00 L/min and not clinically meaningful. There was no significant difference in the week 12 mean FEV increase between the FP and BUD groups (0.237 L/16.79% . 0.236 L/17.73%). Lower limits of the 95% CIs for LS mean treatment difference in morning PEF change from baseline over weeks 1-4 in a analysis were -10.41 and -11.96 L/min in the ITT and PP populations respectively; both above -12.00 L/min. A review of safety data indicated that rates of AEs, SAEs, and drug-related AEs were similar between two groups.
The 12-week treatment of FP inhalation solution administered via nebulizer is safe and effectively for treating severe, persistent asthma in Chinese patients over 12 week.
本研究比较了丙酸氟替卡松（FP）吸入溶液与布地奈德（BUD）混悬液经雾化器吸入给药，对中国成年重度持续性哮喘患者的疗效和安全性。
这是一项在中国26个临床地点进行的多中心、随机、活性对照、单盲、平行组研究。参与者按1:1随机分为每日两次雾化吸入1 mg FP雾化液或每日两次雾化吸入2 mg BUD，为期12周。
共有317例成年患者被随机分组。主要终点是第1 - 12周早晨呼气峰流速（PEF）相对于基线的平均变化，并在意向性分析（ITT，n = 315）和符合方案人群（PP，n = 283）中进行分析。在ITT人群中，第12周时，FP组和BUD组相对于基线的PEF增加分别为26.7 L/min（14.1%）和28.0 L/min（15.3%）；在PP人群中，分别为29.1 L/min（15.7%）和30.1 L/min（16.2%）；所有改善均具有临床意义。最小二乘（LS）均值治疗差异（FP减去BUD）的双侧95%置信区间下限在ITT人群中为-12.19 L/min，在PP人群中为-12.95 L/min，均高于预先设定的非劣效性标准-12.00 L/min，且无临床意义。FP组和BUD组在第12周时平均第一秒用力呼气容积（FEV）增加无显著差异（0.237 L/16.79%对0.236 L/17.73%）。在ITT和PP人群中，1 - 4周早晨PEF相对于基线变化的LS均值治疗差异的95%置信区间下限分别为-10.41和-11.96 L/min；均高于-12.00 L/min。安全性数据回顾表明，两组之间不良事件（AE）、严重不良事件（SAE）和药物相关AE的发生率相似。
经雾化器吸入FP溶液治疗12周对中国患者治疗重度持续性哮喘安全有效。
