跳至主要内容
临床试验/NCT01710930
NCT01710930已完成不适用

Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis

Nantes University Hospital4 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
4
主要终点
The rate of serum TARC

研究概览

简要总结

The main objective of this study is to determine if a doubling of serum TARC (compared to baseline) is associated with the occurrence of exacerbations of ABPA.

The secondary objectives of the study are :

  1. To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
  2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
  3. To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
  4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
  5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE measured at baseline, may be associated with the radiological stage of the disease (ABPA-S, ABPA-CB, ABPA-ORF).
  6. To investigate if there is a link between fungal exposure at home (visually assessed by the contamination level and the proportion of positive samples for Asp. f) and the frequency of exacerbations.
  7. To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Study of predictive factors

Experimental

干预措施: Study of predictive factors (Other)

结局指标

主要结局

The rate of serum TARC

The rate of serum TARC will be measured by ELISA and expressed in pg / ml.Doubling of TARC rate compared between baseline (V1) and exacerbations is the primary endpoint (qualitative binary).

次要结局

  • Biological parameters
  • Induced sputum eosinophils count
  • The rate of Aspf. specific serum IgG
  • Function parameters
  • The rate of Exhaled NO(FeNO50)
  • Clincal parameters
  • The rate of circulating T cells
  • Correlation between markers
  • Fungal exposure at home

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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