Background

Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control.

Objective

This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 μg/50 μg, twice daily).

Methods

Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting β₂-agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits.

Results

Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 ± 0.2 to 6.6 ± 0.2 l/s vs. [DPI] from 6.0 ± 0.2 to 6.9 ± 0.2 l/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events.

Conclusions

Fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 μg/50 μg, twice daily) DPI.

中文翻译：

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一种新的丙酸氟替卡松/沙美特罗在计量吸入器 (MDI HFA) 中的配方可以减少皮质类固醇的日剂量并提供最佳的哮喘控制 - 一项随机、多中心、非劣效性、IV 期临床研究

背景

改进吸入皮质类固醇的给药方法和随后的剂量减少可以最大限度地减少不利结果的风险，同时提供最佳的哮喘控制。

客观的

这项随机、多中心、非劣效性 IV 期临床研究比较了一种新的丙酸氟替卡松/沙美特罗（250 μg/50 μg，每日两次）制剂在定量吸入器氢氟烷烃 (MDI HFA) 中给药的疗效和安全性) 使用含有丙酸氟替卡松/沙美特罗（500 μg/50 μg，每天两次）的干粉吸入器 (DPI)。

方法

患有哮喘的成人 ( n = 231 ) 被随机分配到研究组（用丙酸氟替卡松/沙美特罗 MDI HFA 治疗 12 周）或对照组（用丙酸氟替卡松/沙美特罗 DPI 治疗 12 周）。在四次研究访问期间评估了哮喘症状、恶化、短效 β _{2 -}激动剂 (SABA) 的使用、身体活动、肺功能和一般健康状况。

结果

与参考药物相比，研究药物降低了日间和夜间哮喘症状、哮喘加重、SABA 自我给药和体力活动受限的发生率。峰值呼气流量（[MDI HFA] 从 6.2 ± 0.2 到 6.6 ± 0.2 l/s对比[DPI] 从 6.0 ± 0.2 到 6.9 ± 0.2 l/s；p > 0.05），一秒内用力呼气量的可比改善，两组均获得用力肺活量。在研究组中观察到声音嘶哑的发生率显着降低（[MDI HFA] 0.0% vs. [DPI] 2.8%；p = 0.0267）；其他不良事件没有发现重大差异。

结论

丙酸氟替卡松/沙美特罗（250 μg/50 μg，每天两次）MDI HFA 可提供最佳的哮喘控制，并且不劣于丙酸氟替卡松/沙美特罗（500 μg/50 μg，每天两次）DPI。