Clinical trial NCT00523367: COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux
Chronic Obstructive Pulmonary Disease
Keywords: Gastro Esophageal Reflux Disease (GERD)
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2007-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.
timeFrame: 1 year
Secondary outcomes:
measure: COPD/GERD Patients Treated With High Dose Esomeprazole
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Juan C Munoz, MD
role: PRINCIPAL_INVESTIGATOR
References: