Ignite Creation Date:
2024-05-05 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523367
Status:
TERMINATED
Last Update Posted:
2013-01-18
First Post:
2007-08-30
Brief Title:
COPD Patients Diagnosed With GERDCOPD Exacerbations After Treatment With High Dose PPI
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GERDCOPD
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None