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...
Date First Received: August 30, 2007
Last Updated: June 23, 2008
Verified by: University of Florida, June 2008
Clinical Trial Phase: N/A | Start Date: August 2007
Overall Status: Recruiting
Estimated Enrollment: 20
Brief Summary
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)”
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Other, Prospective
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Florida
Overall Clinical Trial Officials and Contacts
Kenneth Vega, MD Principal Investigator University of Florida - Jacksonville
Overall Contact: Kenneth Vega, MD 904-633-0089 kenneth.vega@jax.ufl.edu
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00523367
Study ID Number: MA-L-147
ClinicalTrials.gov Identifier: NCT00523367
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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