COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI (GERD/COPD)
Primary Purpose
Gastroesophageal Reflux, Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
24 hour pH testing
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastro Esophageal Reflux Disease (GERD), Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- diagnosis of COPD
- forced expiratory volume/forced vital capacity ratio (FEV1/FVC) of < 70% on pulmonary function testing
- age > 40 years
- >20 pack year history of smoking
Exclusion Criteria:
- presence of the following disorders: respiratory disorders other than COPD, known esophageal disease such as cancer, achalasia, stricture, active peptic ulcer disease, Zollinger-Ellison syndrome, mastocytosis, scleroderma, or current abuse of alcohol defined as greater than three alcoholic drinks per day.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
esomeprazole
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.
The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.
Secondary Outcome Measures
COPD/GERD Patients Treated With High Dose Esomeprazole
COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.
Full Information
NCT ID
NCT00523367
First Posted
August 30, 2007
Last Updated
January 15, 2013
Sponsor
University of Florida
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT00523367
Brief Title
COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI
Acronym
GERD/COPD
Official Title
COPD Patients Diagnosed With Gastro Esophageal Reflux Disease Have Decreased Rates of COPD Exacerbations After Treatment With High Dose Proton Pump Inhibitor Therapy (Esomeprazole or Lansoprazole)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
terminated due to enrollment
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Takeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which COPD patients have GERD and if COPD patients with GERD treated with high dose lansoprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.
Detailed Description
Gastroesophageal reflux disease (GERD) is a common esophageal disorder with 40% of the US adult population experiencing symptoms monthly. Pulmonary diseases associated with GERD may include pneumonia, pulmonary fibrosis, asthma, or chronic bronchitis. The latter may be a manifestation of chronic obstructive pulmonary disease (COPD), suggesting GERD as a risk factor for acute exacerbation of COPD. Acute exacerbations of COPD are a major cause of morbidity and mortality in patients with the disease. Recent work suggests that COPD patients with a minimum of weekly reflux symptoms have an increased number of COPD exacerbations that those who are either asymptomatic or have GERD symptoms less than once a week. On this basis, we theorized that in patients with COPD, who also have gastro esophageal reflux disease are at increase risk for acute exacerbations of COPD. To test this question, we will determine which COPD patients have GERD by 24 hour pH testing, treat their GERD with esomeprazole or lansoprazole for 1 year, and compare the number of COPD exacerbations during the treatment period to the previous year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Chronic Obstructive Pulmonary Disease
Keywords
Gastro Esophageal Reflux Disease (GERD), Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esomeprazole
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
24 hour pH testing
Other Intervention Name(s)
Pevacid
Intervention Description
24 hour pH testing will be used to screen patients
Primary Outcome Measure Information:
Title
Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.
Description
The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
COPD/GERD Patients Treated With High Dose Esomeprazole
Description
COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of COPD
forced expiratory volume/forced vital capacity ratio (FEV1/FVC) of < 70% on pulmonary function testing
age > 40 years
>20 pack year history of smoking
Exclusion Criteria:
presence of the following disorders: respiratory disorders other than COPD, known esophageal disease such as cancer, achalasia, stricture, active peptic ulcer disease, Zollinger-Ellison syndrome, mastocytosis, scleroderma, or current abuse of alcohol defined as greater than three alcoholic drinks per day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Munoz, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.hscj.ufl.edu/medicine/research-affairs/search/
Description
University of Florida Research Studies
Learn more about this trial
COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI
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