Phase 2
N=17
Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01983774 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Time to First Pulmonary Exacerbation — NA; NA Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Esomeprazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Pulmonary Exacerbation |
NA; NA | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) |
NA; NA | — |
| SECONDARY Forced Vital Capacity (FVC) |
NA; NA | — |
| SECONDARY Number of Exacerbations |
NA; NA | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01983774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.