一个随机的,双盲交叉研究,对喘参与者剂量注射后肺功能变化,用化-1234ze,为计量剂量吸入器的下一代推进剂,进行了随机的,双盲交叉研究
Roy A Pleasants1,2, Alan S Bell3, Mandeep Jassal4
1Marsico Lung Institute, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Journal of aerosol medicine and pulmonary drug delivery
|June 24, 2025
概括
在计量剂量吸入器 (MDIs) 中的新型化-1234ze (HFO-1234ze) 推进剂与当前的化-134a (HFA-134a) 推进剂一样安全和有效. 这种环保的替代方案对喘患者的肺功能或支气管发作事件没有显著影响.
科学领域:
- 环境科学与公共卫生
- 呼吸系统医学 呼吸系统医学
- 制药技术 制药技术 制药技术
背景情况:
- 压力计量剂量吸入器 (pMDIs) 传统上使用化-134a (HFA-134a),这是一个具有高全球变暖潜力 (GWP) 的推进剂.
- 烯-1234ze (HFO-1234ze) 是一种新兴的近零GWP推进剂,用于pMDIs,提供了一个环境可持续的替代品.
- 喘管理依赖于pMDIs,需要对新推进剂的安全性和有效性进行评估.
研究的目的:
- 评估HFO-1234ze pMDIs与HFA-134a pMDIs相比,在喘患者的剂后肺功能方面具有非劣质性.
- 为了评估单剂量HFO-1234ze和HFA-134a pMDIs后支气管缩事件的发生率.
- 确定HFO-1234ze pMDIs的安全性和耐受性概况,用于患有良好或部分控制喘的人.
主要方法:
- 进行了一项IIIb期,多中心,随机,双盲,单剂量交叉研究.
- 患有良好或部分控制喘的参与者 (n=52) 通过pMDI (四次吸入,没有活性药物) 接受了HFO-1234ze和HFA-134a的单剂量.
- 主要终点:FEV1 AUC0-15分钟的变化;次要终点:支气管,安全性和耐受性.
主要成果:
- 对于FEV1 AUC0-15分钟 (LSM差异: -0.009 L; p=0.492) 确定了HFO-1234ze pMDI与HFA-134a pMDI的非劣势性.
- 在任何治疗组中都没有报告过支气管发作事件.
- 不良事件是罕见的,在不同组之间是可比的;没有观察到严重的不良事件或因AEs而停止治疗.
结论:
- 在喘患者中,HFO-1234ze pMDIs表现出与HFA-134a pMDIs可比的肺功能作用和安全性.
- 这项研究证实HFO-1234ze pMDIs耐受性良好,不会诱导支气管.
- 在慢性呼吸道疾病管理中,HFO-1234ze pMDIs 是一种可行的,环保的推进剂替代 pMDIs.
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