Overview

Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Status:
Terminated

Trial end date:
2011-08-01

Target enrollment:
0

Participant gender:
All

Summary

Gastroesophageal reflux disease 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, esopmeprazole. 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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Columbia University

Treatments:

Esomeprazole
Proton Pump Inhibitors

Criteria

Inclusion Criteria:

1. Cystic fibrosis

2. Age > 18 years

3. Stable maintenance medical regimen during the previous 6 weeks.

4. Negative pregnancy test (women of childbearing potential) at both screening and
baseline visits.

5. Women of childbearing potential must be using medically acceptable contraception.

6. 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:

1. Previous anti-reflux or peptic ulcer surgery,

2. Use of PPI within the past two weeks

3. Pulmonary exacerbation requiring antibiotics within the previous 2 weeks

4. Parenteral hyperalimentation

5. Cigarette smoking

6. Treatment with azoles, iron, anti-coagulants, digitalis

7. Use of any investigative drugs within the previous month.

8. Use of over the counter acid suppressor agents (not including acid neutralizers)