The Leaky Lung Test
A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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New York
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Rochester、New York、美国、14642
- University of Rochester Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria: Asthma The diagnosis of asthma will be based on a consistent history, physical exam, and previous physician diagnosis of asthma. Consistent historical features of asthma include episodic wheezing, shortness of breath, chest tightness, or cough, often precipitated by known environmental triggers (e.g. respiratory viral infection, exposure to pollen, exercise, or stress). Consistent physical findings of asthma include audible expiratory wheezing and findings of associated diseases (e.g. eczema, allergic rhinitis), although the physical exam may be normal in between asthma attacks. Subjects will need to be free of asthma symptoms at time of challenge testing. Most asthmatic subjects should demonstrate bronchial reactivity during the mannitol challenge test.
Inclusion criteria: Non-asthmatic controls Healthy control subjects will be recruited in order to define baseline values for serum and urine mannitol. Healthy control subjects will be defined by the lack of symptoms or physical findings of asthma or other allergic diseases (e.g. eczema, allergic rhinitis), and absence of any other chronic lung disease. Healthy subjects should also not demonstrate bronchial reactivity during a mannitol challenge test.
Exclusion Criteria:
- >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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Asthma
Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
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Subjects will be challenged with inhaled mannitol according to already approved protocols.
其他名称:
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实验性的:Controls
Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.
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Subjects will be challenged with inhaled mannitol according to already approved protocols.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Airway permeability index (Urinary clearance of mannitol overtime)
大体时间:24 hours
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Urinary clearance of mannitol overtime
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)
大体时间:6 hours
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Absorption and clearance of mannitol from the bloodstream
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6 hours
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合作者和调查者
调查人员
- 首席研究员:Steve N Georas, M.D.、University of Rochester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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