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
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
- 2
- 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 :
- To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
- To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
- To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
- To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
- 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).
- 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.
- 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
- 否
入选标准
- •Pre-inclusion criteria :
- •Major patients, of indifferent sex,
- •Patients insured,
- •Patients accepting to give, after information, their signed informed consent form,
- •Patients affected by ABPA,
- •Patients in remission without treatment, or stable under current treatment for at least 3 months.
- •Inclusion criteria :
- •This inclusion will be definitive in V1, if :
- •The pre-inclusion criteria are respected,
- •The patient has not presented any exacerbation since V0 thereby define a basic state.
- •If patient could not be included, it will be possible to re-screen him for the study, provided he meets the pre-inclusion and inclusion criteria. In this case, a new V0 will be scheduled at least 3 months after the first V0.
排除标准
- •Minor patients,
- •Adults under guardianship,
- •Pregnant or lactating women,
- •Patients unable to follow the protocol or to give consent,
- •Patients with an infection of the lower respiratory tract in the 4 weeks preceding V0 or between V0 and V1,
- •Patients who were hospitalized for respiratory problems in the 4 weeks preceding V0 or between V0 and V1,
- •Patients with chronic inflammatory diseases unrelated to ABPA which could influence the results,
- •Patients with cancer,
- •Patients followed for cystic fibrosis defined by a positive sweat test,
- •Patients with known compliance problems identified prior to the study.
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
研究点 (2)
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