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

Study Overview
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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.

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.

Official Title
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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)

Conditions
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Gastroesophageal Reflux, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Procedure: 24 hour pH testing


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: esomeprazole<br> | Procedure: 24 hour pH testing<br>* 24 hour pH testing will be used to screen patients<br>* Other names: Pevacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment. | The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD/GERD Patients Treated With High Dose Esomeprazole | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastro Esophageal Reflux Disease (GERD), Chronic Obstructive Pulmonary Disease (COPD)