Chronic Obstructive Pulmonary Disease (COPD) Patients Diagnosed With Gastro Esophageal Reflux Disease (GERD). Rates of COPD Exacerbations After Treatment With High Dose Proton Pump Inhibitor Therapy

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)”

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

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