Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

January 25, 2022 updated by: Emily DiMango, MD, Columbia University

Effect of Proton Pump Inhibitors on CF Exacerbations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Columbia University Cystic Fibrosis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
A matching placebo (sugar pill) to esomeprazole 40mg twice daily
Drug: Placebo
Sugar pill
Active Comparator: Esomeprazole
Esomeprazole 40mg twice daily
Drug: Esomeprazole
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAC5640

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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