Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Assessment of cellular inflammation in peripheral blood and induced sputum
研究概览
简要总结
Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new equipment will allow the realization of specific standardized bronchial challenges (BC) to occupational agents. Thus, we propose to study in more detail the cellular mechanisms involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients with occupational asthma to wheat flour:
- •Clinical history,
- •A positive skin test to wheat flour and / or specific IgE to wheat flour
- •For patients with occupational asthma to quaternary ammonium compounds:
- •Clinical history,
- •For two types of asthma:
- •Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
- •FEV before challenge (nonspecific and specific) must be> 70%.
排除标准
- •no occupational asthma:
- •secondary to clinically relevant sensitization to an allergen domestic
- •aggravated at work.
结局指标
主要结局
Assessment of cellular inflammation in peripheral blood and induced sputum
时间窗: 33 months
Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.
次要结局
未报告次要终点