Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

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

Official Title
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Effect of Proton Pump Inhibitors on CF Exacerbations

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A matching placebo (sugar pill) to esomeprazole 40mg twice daily | Drug: Placebo<br>* Sugar pill<br>|
| Active Comparator: Esomeprazole<br>Esomeprazole 40mg twice daily | Drug: Esomeprazole<br> <br> * Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Pulmonary Exacerbation | Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure. | 36 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CF