Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Placebo; Drug: Esomeprazole

• Registration Number: NCT01983774
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-14
• Status Verified: 2022-01
• Results First Submitted: 2022-01-25
• Results First Submitted QC: 2022-01-25
• Last Update Submitted: 2022-01-25
• Results First Posted: 2022-02-17
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A matching placebo (sugar pill) to esomeprazole 40mg twice daily
Esomeprazole	Esomeprazole	Esomeprazole 40mg twice daily

Primary Outcome Measures

Name	Time	Method
Time to First Pulmonary Exacerbation	36 weeks	Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure.

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	36 weeks	Forced Vital Capacity percent predicted
Number of Exacerbations	36 weeks	Exacerbation defined as initiation of treatment with intravenous or oral antibiotics for 7 or more days based on respiratory symptoms
Forced Expiratory Volume in One Second (FEV1)	36 weeks	Forced Expiratory Volume in one second (FEV1) as measured by spirometry

Trial Locations

Locations (1)

Columbia University Cystic Fibrosis Center; 🇺🇸 New York, New York, United States