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 - Full Text View

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 (GERD/COPD)

This study is currently recruiting participants.

Verified by University of Florida, June 2008

First Received: August 30, 2007 Last Updated: June 23, 2008 History of Changes

Sponsor:	University of Florida
Collaborator:	TAP Pharmaceutical Products Inc.
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00523367

Purpose

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.

Condition
Gastroesophageal Reflux Chronic Obstructive Pulmonary Disease

Study Type:	Observational
Study Design:	Prospective
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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Esophagus Disorders GERD

U.S. FDA Resources

Further study details as provided by University of Florida:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	August 2007

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Male or females
greater than or equal to 40 years of age
diagnosis of COPD
>20 pack year history of smoking

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523367

Contacts

Contact: Kenneth Vega, MD

904-633-0089

kenneth.vega@jax.ufl.edu

Locations

United States, Florida
University of Florida	Recruiting
Jacksonville, Florida, United States, 32207
Contact: Kenneth Vega, MD 904-633-0089 kenneth.vega@jax.ufl.edu
Contact: Lakina Campbell, MS, CCRP 904-633-0089 lakina.campbell@jax.ufl.edu
Principal Investigator: Kenneth Vega, MD

Sponsors and Collaborators

University of Florida

TAP Pharmaceutical Products Inc.

Investigators

Principal Investigator:

Kenneth Vega, MD

University of Florida - Jacksonville

More Information

No publications provided

Responsible Party:	University of Florida ( Kenneth Vega, MD / Associate Professor )
Study ID Numbers:	MA-L-147
Study First Received:	August 30, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00523367 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Gastro Esophageal Reflux Disease (GERD)
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Respiration Disorders
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders

Lung Diseases, Obstructive
Digestive System Diseases
Respiratory Tract Diseases
Proton Pump Inhibitors
Lung Diseases
Esophageal Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010