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

Chronic Obstructive Pulmonary Disease Clinical Trial

— GERD/COPD  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523367
• Other study ID #: MA-L-147
• 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

• Chronic Obstructive Pulmonary Disease
• Gastroesophageal Reflux
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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

External Links

•   University of Florida Research Studies