COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI (GERD/COPD)
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.
Chronic Obstructive Pulmonary Disease
Procedure: 24 hour pH testing
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.
- COPD/GERD Patients Treated With High Dose Esomeprazole [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|No Intervention: esomeprazole||
Procedure: 24 hour pH testing
24 hour pH testing will be used to screen patients
Other Name: Pevacid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523367
|United States, Florida|
|University of Florida|
|Jacksonville, Florida, United States, 32207|
|Principal Investigator:||Juan C Munoz, MD||University of Florida|