Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Columbia University

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Esomeprazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01983774

AAAC5640

Details and patient eligibility

About

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.

Full description

This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 proton pump inhibitor (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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A matching placebo (sugar pill) to esomeprazole 40mg twice daily

Treatment:

Drug: Placebo

Esomeprazole

Active Comparator group

Description:

Esomeprazole 40mg twice daily

Treatment:

Drug: Esomeprazole