Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs COPD Patients Without Bronchiectasis
试验速览
- 阶段
- 不适用
- 发起方
- Wim Janssens
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bronchiectasis
研究概览
简要总结
A single center case-control study with 100 COPD patients will be organized to compare patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized for culture, Aspergillus galatomannan analysis and RT-PCR.
This study is part of a larger project in which we assume that chronic respiratory infection by Aspergillus fumigatus and the accompanying immune response play an important role in the development of bronchiectasis in COPD. We suspect that this mechanism is controlled by vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.
The present study is designed by the Laboratory of pneumology and will be conducted in collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic University of Leuven.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Established diagnosis of COPD by medical doctor (based on clinical history or pulmonary function test)
- •Smoking history of at least 10 pack-years
- •CT Thorax available for assessment of bronchiectasis
- •FEV1 >= 30%
排除标准
- •Mechanical or non-invasive ventilation
- •Other main respiratory diagnosis other than COPD
- •Active mycobacterial disease
- •Immunosuppression other than steroids
- •Active cancer treatment
结局指标
主要结局
Bronchiectasis
时间窗: immediate
次要结局
- Prevalence of Aspergillus sensitization(max 12weeks)
- Vitamin D(immediate)
- Prevalence of Aspergillus isolation in sputum(max 12weeks)