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Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01983774
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : February 17, 2022
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Emily DiMango, MD, 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Esomeprazole Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Proton Pump Inhibitors on CF Exacerbations
Study Start Date : February 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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 Name: Nexium




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 36 weeks ]
    Forced Expiratory Volume in one second (FEV1) as measured by spirometry

  2. Forced Vital Capacity (FVC) [ Time Frame: 36 weeks ]
    Forced Vital Capacity percent predicted

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983774


Locations
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United States, New York
Columbia University Cystic Fibrosis Center
New York, New York, United States, 10003
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Emily DiMango, MD Columbia University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emily DiMango, MD, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01983774    
Other Study ID Numbers: AAAC5640
First Posted: November 14, 2013    Key Record Dates
Results First Posted: February 17, 2022
Last Update Posted: February 17, 2022
Last Verified: January 2022
Keywords provided by Emily DiMango, MD, Columbia University:
CF
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action