Inhaled Bicarbonate Therapy in Cystic Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation
研究概览
简要总结
The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough up mucus in a person with cystic fibrosis.
详细描述
There is evidence that people with CF may have differences in the liquid that lines the surface of their lungs from people without CF. There are two things that are known to be different. One is called bicarbonate secretion, which is the movement of a salt called bicarbonate that is normally present in the blood and lung fluid in all people. The abnormal movement of bicarbonate appears to cause a second abnormality - the liquid in the breathing tubes has more acid than the liquid in patients without CF. These differences may affect the stickiness and thickness of the mucus and limit how well the hairs that line the breathing tubes (cilia) move mucus out of the lungs.
Recent studies in a group of patients with chronic cough looked at the effects of giving an inhaled bicarbonate solution (sodium bicarbonate instead of sodium chloride) on the study subjects' ability to cough up mucus. Compared to the group given inhaled saline, the patients given inhaled bicarbonate were able to cough up approximately three times as much mucus. No clinical studies have looked at whether inhaled bicarbonate improves the ability of the lung in a person with CF to move mucus out of the lung or how this treatment affects lung function in patients with CF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •age 12 or older
- •Forced expiratory volume in one second (FEV1) >40% predicted
- •Ability to expectorate sputum
排除标准
- •pregnancy
- •pulmonary exacerbation or initiation of inhaled or oral antibiotics, steroids, or aerosol treatments within the last four weeks
- •oxygen saturation <92%, or requirement for supplemental oxygen
结局指标
主要结局
Determine the acute effects of increasing doses of inhaled bicarbonate on mucociliary clearance after a single inhalation
时间窗: single dose escalation
次要结局
- Safety as determined by pre- and post-clearance assay pulmonary function tests (FEV1) at a single visit(two doses in single day)
- comparison of pre- and post-bicarbonate exhaled breath condensate pH values at a single inhalation(two doses in single day)
