NCT01150591已完成不适用
The Role of Microaspiration in Idiopathic Pulmonary Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- BAL pepsin level
研究概览
简要总结
Hypothesis 1: Microaspiration, as diagnosed by bronchoalveolar lavage (BAL) pepsin, is common in patients with IPF.
Hypothesis 2a: Baseline clinical variables and co-morbid conditions are risk factors for microaspiration in patients with IPF.
Hypothesis 2b: Baseline biological variables reflecting alveolar epithelial injury and inflammation are markers of microaspiration in IPF.
Hypothesis 3a: Microaspiration will lead to a more rapid rate of decline in pulmonary function.
Hypothesis 3b: Microaspiration will lead to higher rates of urgent medical care use (i.e. unscheduled clinic visit, emergency room visit, or hospitalization).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IPF
- •Ability ot provide informed consent
排除标准
- •History of fundoplication or other gastroesophageal surgery
- •Too ill to undergo bronchoscopy in the opinion of the investigator
结局指标
主要结局
BAL pepsin level
时间窗: Cross sectional
次要结局
未报告次要终点
研究者
研究点 (1)
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