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在患有非控制性喘的患者中,FF/UMEC/VI的实用性RCT:PERFORM协议
Stephen G Noorduyn1,2, Nicola Brown3, Jodie Crawford4
1Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada. stephen.g.noorduyn@gsk.com.
Pulmonary therapy
|February 11, 2026
概括
PERFORM试验比较了单吸入器三重疗法 (SITT) 和非控制性喘的常规护理. 这项实用性试验将评估在常规临床实践中代表性的广泛患者群体中的有效性.
科学领域:
- 呼吸系统医学 呼吸系统医学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 喘影响了许多患者,尽管标准的吸入性皮质类固醇/长效β2抗原剂 (ICS/LABA) 治疗,但大约一半的患者经历了不受控制的症状.
- 之前的研究表明,在特定的喘患者群体中,单吸入式三重疗法 (SITT) 具有流动松酸/乌梅克利迪尼/维兰特罗尔 (FF/UMEC/VI) 的益处.
- 在广泛的非控制性喘患者中,对于有效的治疗方法存在重大未满足的需求.
研究的目的:
- 介绍PERFORM实用试验的协议,这是一项全球性研究,将FF/UMEC/VI SITT与非控制性喘的常规护理进行比较.
- 在广泛的患者群体中,评估启动FF/UMEC/VI SITT与继续或启动非ELLIPTAICS/LABA治疗的有效性.
- 在常规临床实践中生成关于控制不下的喘管理的真实数据.
主要方法:
- PERFORM试验是一项为期52周的随机化,开放标签,主动控制的全球实用性研究.
- 目前未接受ICS或ICS/LABA治疗或接受ICS或ICS/LABA治疗的非控制性喘的成年患者将被随机分配1:1到FF/UMEC/VI SITT或非ELLIPTAICS/LABA常规护理.
- 主要终点是24周内1秒内 (FEV1) 最低强迫呼气体积与基线的变化. 关键的次要终点包括喘控制问卷-7 (ACQ-7) 的得分改善.
主要成果:
- 在数据收集完成后,本部分将报告 PERFORM 试验的结果.
- 这项研究旨在随机选择1136名患者,以评估治疗的有效性.
- 预期的结果将为管理失控喘的临床实践提供信息.
结论:
- PERFORM试验旨在提供关于FF/UMEC/VI SITT在广泛的非控制性喘患者中有效性的有价值数据.
- 这项务实的试验将为高度控制的研究环境之外的喘管理提供洞察力.
- 该研究还将为接受吸入性喘治疗的患者的临床缓解提供新的前性数据.
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