跳至主要内容
临床试验/NCT05706597
NCT05706597招募中不适用

Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

Medical Centre Leeuwarden1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment?

研究概览

简要总结

The aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-IL5/5R therapy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Severe asthma patients treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months.

排除标准

  • No information about lung function at baseline, or after both 4 months and 12 months.
  • No information about clinical response (i.e. number of exacerbations, reduction of mOCS/ maintenance oral corticosteroid dose, ACQ, AQLQ) after both 4 months and 12 months.
  • Treatment with another anti-IL5/5R therapy before

结局指标

主要结局

Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment?

时间窗: 4 months and 12 months

Is change in FEF25-75 during anti-IL5/5R treatment associated with change in asthma control (measured with the asthma control questionnaire -ACQ-) in severe eosinophilic asthma patients after 4 months and after 12 months treatment?

次要结局

未报告次要终点

研究者

发起方
Medical Centre Leeuwarden
申办方类型
Other
责任方
Sponsor

研究点 (1)

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