SCCOR in Host Factors in Chronic Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mucociliary clearance of inhaled tc99m
研究概览
简要总结
The purpose of this research is to understand the properties of mucus in persons with COPD, specifically Chronic Bronchitis. We hypothesize that those with Chronic Bronchitis have dehydrated mucus, and thus have a harder time coughing it out of their lungs. This leads to a greater vulnerability for lung infection, inflammation and airflow obstruction. Ultimately, our goal is to understand how mucus dehydration contributes to the progression of COPD/Chronic Bronchitis so that better therapies and interventions can be developed for future generations.
详细描述
Specific Aim I directly tests the hypothesis that mucus clearance is impaired due to mucus dehydration. It measures 1) COPD Mucociliary and Cough Clearance 2) mucus hydration 3) the concentrations of the dominant regulators of airway hydration and 4) the consequences of mucus dehydration on mucus biophysical properties and bacterial infection.
Specific Aim II tests the hypothesis that COPD acute exacerbations are associated with failures of mucus clearance. Measurements will be similar to that of Specific Aim I, but conducted during periods of baseline health, acute exacerbation and recovery.
Specific Aim III tests whether airway surface hydration with 7% Hypertonic Saline will restore clearance in the basal state and during a COPD acute exacerbation. COPD subjects will be exposed to inhaled Hypertonic Saline during periods of baseline health and acute exacerbation. Acute efficacy via measures of mucus clearance and spirometry will studied.
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 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of COPD/chronic bronchitis defined as having a productive cough for three months of the year for at least two successive years
- •greater than or equal to a 10 pack year cigarette smoking history
- •ability to perform spirometry
排除标准
- •unstable lung disease
- •allergy to study medications
- •radiation exposure within past year exceeding Federal Regulation Limits
结局指标
主要结局
Mucociliary clearance of inhaled tc99m
时间窗: 24 hours
次要结局
- Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus(March 2012)
研究者
Richard C Boucher, MD
Director of Cystic Fibrosis Center
University of North Carolina, Chapel Hill