Effect of Proton Pump Inhibitors on CF Exacerbations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Time to First Pulmonary Exacerbation
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if there are fewer respiratory infections and improved lung function in patients with CF when taking esomeprazole.
详细描述
This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis
- •Age > 18 years
- •Stable maintenance medical regimen during the previous 6 weeks.
- •Negative pregnancy test (women of childbearing potential) at both screening and baseline visits.
- •Women of childbearing potential must be using medically acceptable contraception.
- •At least two respiratory exacerbations per year requiring oral and/or intravenous antibiotics for each of the two years prior to study entry, but no more than 4 exacerbations requiring intravenous antibiotics during either of those years.
排除标准
- •Previous anti-reflux or peptic ulcer surgery,
- •Use of proton pump inhibitor (PPI) within the past two weeks
- •Pulmonary exacerbation requiring antibiotics within the previous 2 weeks
- •Parenteral hyperalimentation
- •Cigarette smoking
- •Treatment with azoles, iron, anti-coagulants, digitalis
- •Use of any investigative drugs within the previous month.
- •Use of over the counter acid suppressor agents (not including acid neutralizers)
研究组 & 干预措施
Placebo
A matching placebo (sugar pill) to esomeprazole 40mg twice daily
干预措施: Placebo (Drug)
Esomeprazole
Esomeprazole 40mg twice daily
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Time to First Pulmonary Exacerbation
时间窗: 36 weeks
Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure.
次要结局
- Forced Vital Capacity (FVC)(36 weeks)
- Number of Exacerbations(36 weeks)
- Forced Expiratory Volume in One Second (FEV1)(36 weeks)
研究者
Emily DiMango, MD
Associate Professor
Columbia University