Modifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ Channels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Exhaled Sodium (mmol/L)
研究概览
简要总结
Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC chloride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •no cardiovascular abnormalities
- •not overweight BMI>25
- •18-55 years of age
- •CF subjects:
- •mild to moderate CF (FEV1>40% predicted)
- •clinically diagnosed with positive sweat test (sweat Cl->60mmol/L)
- •10-55 years of age
- •clinically stable
排除标准
- •Healthy subjects will be excluded if:
- •If unable to consent for him/herself (cognitive impairment)
- •Have a history or evidence of cardiovascular and/or pulmonary abnormalities.
- •Have an abnormal 12-lead EKG
- •Have an abnormal pulmonary function test
- •Have a history of asthma
- •Have a history of renal disease or estimated creatinine clearance < 55ml/min
- •Women who are pregnant or planning to become pregnant during the study
- •CF subjects:
- •If unable to consent for him/herself (cognitive impairment)
- •Physically unable to perform exercise or breathing tests
- •Have a history of renal disease or estimated creatinine clearance < 55ml/min
- •Women who are pregnant or planning to become pregnant during the study.
- •Have an abnormal 12-lead EKG
- •Cystic Fibrosis related diabetes is uncontrolled
- •Forced Expiratory Volume after 1 second (FEV1) is less than 40% predicted
- •Have a history of joint disease
- •Have history of pulmonary exacerbation within the last two weeks
- •Experienced pulmonary hemorrhage within 6 months resulting in greater than 50cc of blood in the sputum
- •not currently enrolled in any other research study
研究组 & 干预措施
Albuterol
2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer
干预措施: Albuterol (Drug)
Saline (healthy only)
nebulized 3 ml normal saline using a Power Neb2 nebulizer
干预措施: Placebo saline (Drug)
结局指标
主要结局
Exhaled Sodium (mmol/L)
时间窗: up to 90-minutes post albuterol
We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.
Net Exhaled Chloride
时间窗: baseline to 90 minutes post albuterol administration
The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point: Net Cl- efflux - \[Cl- X-min post\] + ((\[Na+ X-min post\]-\[Na+Baseline\])/ \[Na+Baseline\]) x \[Cl- X-min post\])
次要结局
- Diffusion Capacity of the Lungs for Carbon Monoxide(baseline, 30-, 60- and 90-minutes post albuterol administration)
- Diffusion Capacity of the Lungs for Nitric Oxide(baseline, 30-, 60- and 90-minutes post albuterol administration)
- Peripheral Oxygen Saturation(baseline, 30-, 60- and 90-minutes post albuterol)
研究者
Courtney Wheatley
Graduate Research Assistant
University of Arizona