Absorptive Clearance in the Cystic Fibrosis Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Absorptive Clearance Rate
研究概览
简要总结
The objective of this overall project is to develop a new aerosol-based technique for quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be used to help develop new therapies. In CF, mutations in the CF gene result in dysfunction of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) ion channel on the cells that line the airway epithelium, causing improper fluxes of ions such as sodium, chloride, and bicarbonate. The so called "low volume" hypothesis of CF pathogenesis contends that abnormal absorption of ions from the airways causes excessive absorption of liquid, resulting in an airway surface liquid layer that is dehydrated and difficult to clear. Here we are measuring the absorption rate of a radiolabeled small molecule (DTPA) from the lungs of cystic fibrosis patients and healthy controls. We hypothesize that the molecule will absorb more quickly in cystic fibrosis patients. Further studies will be performed to determine if DTPA absorption is related to liquid absorption in the airways.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cystic fibrosis subjects and healthy controls
- •Age ≥ 18 years
- •Diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical symptoms (CF subjects)
- •Clinically stable as determined by the investigator (pulmonologist)
排除标准
- •Reactive airways disease
- •Tobacco smokers (regular smoking within 6 months of enrollment)
- •Positive urine pregnancy test on the day of testing
- •FEV1p value of < 50%
- •SaO2 < 92%, or if they require supplemental oxygen.
- •Subjects performing other radioisotope studies within the last 2 weeks will be excluded.
- •Healthy subjects with any history of lung disease will be excluded.
- •Women currently breastfeeding
- •Subjects not willing to stop treatments with inhaled hypertonic saline for 48 hours in advance of the study.
研究组 & 干预措施
cystic fibrosis
Cystic fibrosis patients
干预措施: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA (Other)
healthy controls
Healthy control subjects
干预措施: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA (Other)
结局指标
主要结局
Absorptive Clearance Rate
时间窗: single measurement
The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.
次要结局
- Mucociliary Clearance Rate(single measurement)
研究者
Tim Corcoran
Assistant Professor
University of Pittsburgh