Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Alveolar Macrophage
研究概览
简要总结
Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with impaired host defense function against Mtb and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.
详细描述
Samples from Non-Smokers with TB, Smokers with TB and Smokers with COPD and TB will be collected in Qatar under JIRB 14-00055. All subjects will be undergoing a clinical bronchoscopy as part of their disease evaluation and will be asked to give additional samples for research. All "in vivo" processing of specimens from subjects with TB will be performed in Qatar. Mycobacterium tuberculosis infection (Mtb) continues to have a detrimental impact of public health worldwide. Based on the epidemiological evidence linking smoking, COPD and Mtb, and our preliminary data we hypothesize that smoking reprograms Alveolar Macrophages (AM) polarization towards a distinct phenotype associated with impaired host defense function against Myobacterium tuberculosis (Mtb) and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophages (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must provide informed consent
- •Current smokers and non-smokers
- •Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
- •Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
- •Symptoms consistent with TB
- •Chest xray and or chest CT with TB
- •Positive PPD test
- •Positive sputum test
排除标准
- •Females who are pregnant or nursing
- •History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic
- •Smokers with TB and COPD
- •Inclusion Criteria:
- •Must provide informed consent
- •Current smokers with COPD
- •Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
- •Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed bu at least one of the following:
- •Symptoms consistent with TB
- •Chest xray and or chest CT consistent with TB
- •Positive PPD test
- •Positive sputum test
- •Exclusion Criteria:
- •Non-smokers
- •Females who are pregnant or nursing
- •History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic
结局指标
主要结局
Alveolar Macrophage
时间窗: 1 week
Changes in alveolar macrophage
次要结局
未报告次要终点