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临床试验/NCT01224938
NCT01224938已完成不适用

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 395 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
395
试验地点
1
主要终点
sputum cytokine mRNA

研究概览

简要总结

The main objectives of the study are

  1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of healthy subjects and clinically different asthma patients, based on a non-invasive procedure of sputum induction. Patients will be different in function of age, in relation to the trigger (eg aspirin, without or with association with polyposis), without or with underlying atopic sensitization or different in the type of underlying inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis of molecular phenotyping in the patients.
  2. to study the usefulness of asthma molecular phenotyping (by following the balance between the inflammatory markers on the one hand and the regulatory markers on the other hand) in asthma guidance (longitudinally).

The final goal of this project is then to develop a sputum non-invasive biomarker array that can be used to distinguish the different inflammatory asthma phenotypes and that can predict steroid resistance and/or sensitivity to other anti-inflammatory medication, using a non-invasive technique that can be used also at young age and repetitively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • asthma diagnosis

排除标准

  • viral/bacterial/fungal infection with fever (<1 month )
  • other airway diseases (CF, ciliar dyskinesia, bronchiectasis)
  • asthma exacerbation (<3 months)

结局指标

主要结局

sputum cytokine mRNA

时间窗: one year

次要结局

  • lung function parameters(one year)
  • asthma symptom scores(one year)
  • non-invasive measurements of airway inflammation(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominque Bullens

prof. dr.

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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