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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00523367
Other study ID # MA-L-147
Secondary ID
Status Terminated
Phase N/A
First received August 30, 2007
Last updated January 15, 2013
Start date August 2007
Est. completion date October 2010

Study information

Verified date January 2013
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
24 hour pH testing
24 hour pH testing will be used to screen patients

Locations

Country Name City State
United States University of Florida Jacksonville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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