Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Exhaled breath condensate pH change
研究概览
简要总结
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
详细描述
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 greater than 50% predicted.
- •Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
- •Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment.
排除标准
- •Reactive airway disease
- •Use of inhaled hypertonic saline in the past 28 days
- •Use of IV antibiotics in the past 4 weeks
- •Changes in CF-related medications in the four weeks prior to study screening
- •SpO2 < 94% on room air or use of supplemental oxygen.
- •Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux symptoms in cases of treated GERD more than three times per week.
- •Pregnant or nursing females.
研究组 & 干预措施
hypertonic bicarbonate
subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer
干预措施: hypertonic bicarbonate (Drug)
hypertonic saline
subjects will be administered a solution of 7% sodium chloride by nebulizer
干预措施: sodium chloride (Drug)
结局指标
主要结局
Exhaled breath condensate pH change
时间窗: two time points (baseline and four (4) hours)
Change in pH after inhalation of two doses on one day
次要结局
- Expectorated sputum change(two time points (Baseline and four (4) hours))
- Spirometry(two time points (baseline and four (4) hours))
研究者
Joseph Pilewski
Associate Professor of Medicine and Pediatrics
University of Pittsburgh