A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Airway permeability index (Urinary clearance of mannitol overtime)
研究概览
简要总结
This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.
详细描述
A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. This is a proof of concept study and not a trial of new therapeutics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •>5 pack year history of tobacco use or active smoking.
- •Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
- •History of significant renal insufficiency of liver disease
- •Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
- •Asthma subjects with a baseline FEV1<65% predicted
- •Asthma subjects unwilling or unable to withhold medications prior to testing
- •Pregnant women.
研究组 & 干预措施
Asthma
Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
干预措施: Mannitol (Drug)
Controls
Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.
干预措施: Mannitol (Drug)
结局指标
主要结局
Airway permeability index (Urinary clearance of mannitol overtime)
时间窗: 24 hours
Urinary clearance of mannitol overtime
次要结局
- Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)(6 hours)
研究者
Steve Nicholas Georas
Professor of Medicine
University of Rochester