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COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI (GERD/COPD)

This study has been terminated.
(terminated due to enrollment)
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00523367
First received: August 30, 2007
Last updated: January 15, 2013
Last verified: January 2013
  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 Intervention
Gastroesophageal Reflux
Chronic Obstructive Pulmonary Disease
Procedure: 24 hour pH testing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.


Secondary Outcome Measures:
  • COPD/GERD Patients Treated With High Dose Esomeprazole [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.


Enrollment: 25
Study Start Date: August 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: esomeprazole Procedure: 24 hour pH testing
24 hour pH testing will be used to screen patients
Other Name: Pevacid

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Juan C Munoz, MD University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00523367     History of Changes
Other Study ID Numbers: MA-L-147
Study First Received: August 30, 2007
Results First Received: March 8, 2012
Last Updated: January 15, 2013
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:
Gastroesophageal Reflux
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014