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

Not Applicable

Terminated

• Conditions: Gastroesophageal Reflux; Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: 24 hour pH testing

• Registration Number: NCT00523367
• Lead Sponsor: University of Florida

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2012-03-08
• Results First Submitted QC: 2012-06-18
• Results First Posted: 2012-07-24
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
esomeprazole	24 hour pH testing	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.	1 year	The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.

Secondary Outcome Measures

Name	Time	Method
COPD/GERD Patients Treated With High Dose Esomeprazole	1 year	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States