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临床试验/NCT01224951
NCT01224951Unknown不适用

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
sputum cytokine mRNA levels

研究概览

简要总结

The main objectives of the study are:

-to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids)

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

  1. different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
  2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.
  3. these subgroups have different responses to anti-inflammatory treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • steroid naive asthmatics

排除标准

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

研究组 & 干预措施

Qvar 100

Active Comparator

Patients will be randomized to receive either the active arm (3/4) or a SABA as rescue medication (1/4). The patient will be asked to take Qvar 100 (2puffs) in the morning and in the evening.

Daily dose (400 microgram).

干预措施: Beclomethasone (Drug)

结局指标

主要结局

sputum cytokine mRNA levels

时间窗: 6 and 10 weeks

次要结局

  • steroid-responsiveness(6 and 10 weeks)

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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