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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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esomeprazole

Group Type NO_INTERVENTION

24 hour pH testing

Intervention Type PROCEDURE

24 hour pH testing will be used to screen patients

Interventions

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24 hour pH testing

24 hour pH testing will be used to screen patients

Intervention Type PROCEDURE

Other Intervention Names

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Pevacid

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No