NCT00295737终止不适用
05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin
Fraunhofer-Institute of Toxicology and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- number of macrophages in bronchoalveolar lavage
研究概览
简要总结
The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage (BAL) for different in vitro experiments.
Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into three different lung segments during the first bronchoscopy. After 24 hours during a second bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken to assess the degree of local inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
- •Age 18-55 years
- •Nonsmoker (> 5 years)
- •Forced expiratory volume in 1 second (FEV1) > 70% of the predicted value
- •A positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
- •Informed consent
- •Females with negative pregnancy test
排除标准
- •Infections of the respiratory tract within the last month
- •Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- •Pathological findings in blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
- •Subject is undergoing allergen desensitization therapy
- •Permanent medication
- •Systemic or inhaled corticosteroid use within the last month
- •Anti-inflammatory medication within the last month
- •Pregnancy
- •Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
- •There is a risk of non-compliance with study procedures
- •Participation in a clinical trial 30 days prior to enrolment
结局指标
主要结局
number of macrophages in bronchoalveolar lavage
时间窗: one day after challenge
次要结局
- number of other BAL cells(one day after challenge)
研究者
研究点 (2)
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