在耐药慢性咳中使用Camilipixant:一个2b期,随机的,安慰剂对照试验 (SOOTHE)
Jaclyn A Smith1, Surinder S Birring2, Michael S Blaiss3
1University of Manchester and Manchester University NHS Foundation Trust, , Manchester, United Kingdom of Great Britain and Northern Ireland; jacky.smith@manchester.ac.uk.
概括
卡姆利皮克桑 (Camilipixant) 是一种P2X3抗剂,在成年人中显著降低了耐火性慢性咳的频率. 这项研究发现camlipixant耐受性很好,为慢性咳患者提供了一个有前途的新治疗方案.
科学领域:
- 肺部病理学 肺部病理学
- 临床药理学 临床药理学
背景情况:
- 耐火性慢性咳 (RCC) 缺乏有效的,广泛可用的治疗方法.
- RCC显著影响患者的生活质量.
研究的目的:
- 评估Camilipixant的疗效和安全性,一个P2X3抗剂,在成年人与RCC.
- 评估卡姆利皮克桑对咳频率,严重程度和生活质量的影响.
主要方法:
- 一个2b期,随机的,安慰剂对照试验 (SOOTHE,NCT04678206) 涉及310名患有RCC的成年患者.
- 患者在16天的安慰剂运行后,接受了卡姆利皮克森特 (12.5,50或200毫克两次) 或安慰剂4周.
- 主要终点:从基线到28日24小时咳频率的变化.
主要成果:
- 使用50毫克 (-34.4%) 和200毫克 (-34.2%) 坎利皮克森特相对于安慰剂,24小时咳频率的统计显著降低.
- 改善咳严重程度和生活质量得分的趋势,涉及所有卡姆利皮克桑剂量.
- 卡姆利皮克桑被很好地容忍;味道改变是最常见的副作用 (4.8-6.5%).
结论:
- 卡姆利皮克桑在降低耐性慢性咳患者咳频率方面表现出显著的有效性.
- 该P2X3抗剂显示出可接受的安全性概况,报告了轻度至中度的味道变化.
- 卡姆利皮克桑特是一种潜在的新疗法选择,用于耐火性慢性咳.
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