Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL
研究概览
简要总结
This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case definition: Smokers (>20 pack-year) with airflow obstruction (FEV1/FVC<70) and FEV1>50% predicted (early COPD GOLD 1 or 2)
- •Control definition: Smokers with normal spirometry will serve as controls.
排除标准
- •FEV1 < 50% NOT 70
- •Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
- •Diabetes mellitus
- •Significant liver or renal disease
- •Severe coagulopathy (INR > 1.4, PTT > 40 seconds and platelet count < 150x103 cells).
- •Pregnancy
- •ETOH use of more than >6 beers or >4 mixed drinks daily
- •Lack of capacity to provide informed consent.
- •Antibiotic use within the prior 2months
研究组 & 干预措施
Chronic Obstructive Pulmonary Disease (COPD)
Case of early COPD (GOLD 1-2, FEV1/FVC<70 and FEV1>50%)
干预措施: Bronchoscopy (Procedure)
Control
No obstruction (FEV1/FVC<70). Controls will be recruited after each case and will be matched by: age (±5 year), 2) gender, 3) smoking (±5 pack-year) and 4) BMI (±5).
干预措施: Bronchoscopy (Procedure)
结局指标
主要结局
Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL
时间窗: 4 Hours
次要结局
- Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches(4 Hours)