Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-08-31

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.

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill

Esomeprazole

Esomeprazole 40mg twice daily

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Interventions

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Esomeprazole

Intervention Type DRUG

Placebo

Sugar pill

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No