Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Completed · Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01983774
- Run by
- Columbia University
- People needed
- 21
- Starts
- 2008-02-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2022-02-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Columbia University Cystic Fibrosis Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.