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 has been completed.

First Received on August 30, 2007. Last Updated on October 21, 2010 History of Changes

Sponsor:	University of Florida
Collaborator:	Takeda Global Research & Development Center, 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:	Time Perspective: 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:

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Study Completion Date:	October 2010

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

Locations

United States, Florida
University of Florida
Jacksonville, Florida, United States, 32207

Sponsors and Collaborators

University of Florida

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:

Juan C Munoz, MD

University of Florida - Jacksonville

More Information

Additional Information:

University of Florida Research Studies This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Juan C. Munoz, MD / Assistant Professor, University of Florida
ClinicalTrials.gov Identifier:	NCT00523367 History of Changes
Other Study ID Numbers:	MA-L-147
Study First Received:	August 30, 2007
Last Updated:	October 21, 2010
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:

Esophageal Diseases
Gastroesophageal Reflux
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Gastrointestinal Diseases
Digestive System Diseases

Esophageal Motility Disorders
Deglutition Disorders
Respiratory Tract Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012