NCT01337661已完成不适用
An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Identification of how inflammatory pathways differ in COPD subjects
研究概览
简要总结
The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).
详细描述
This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
- •Current or ex-smoker with a tobacco history of 15 or more pack years
- •Females of childbearing potential must use birth control for the duration of the study.
排除标准
- •Evidence or history of clinically significant disease
- •Subjects with asthma
- •Subjects taking anti-leukotriene medications
结局指标
主要结局
Identification of how inflammatory pathways differ in COPD subjects
时间窗: 6 weeks
Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.
次要结局
- Biomarker Sample Repository(6 weeks)
研究者
研究点 (1)
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