Overview

Elucidation of Acid-Induced Pulmonary Inflammation

Status:
Terminated
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the study will determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by gastroesophageal reflux (GER).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Utah
Treatments:
Dexlansoprazole
Lansoprazole
Criteria
Inclusion Criteria:

1. chronic cough consistent with bronchoreactivity

2. Gastroesophageal reflux

Exclusion Criteria:

1. Severe asthmatics who have been hospitalized within the last 6 months or who have
required oral steroid use within the last 4 weeks

2. Severe coronary artery disease

3. Cigarette/cigar smoking within the last 6 months

4. Documented allergies affecting the respiratory system

5. Subjects with contraindications to pH/impedance probe

1. Hemophilia

2. Septal deviation

6. Subjects with contraindications to bronchoscopy as outlined by the American Thoracic
Society Guidelines

7. Anticoagulation

8. Pregnancy

9. Incarcerated patients

10. Current oral steroid use (may suppress levels of inflammation)

11. Upper respiratory infection within the last 2 weeks

12. Ongoing acid suppression with a proton pump inhibitor, however, patients may be
included if they have discontinued their proton pump inhibitor within the last 1 month
with stable asthma symptoms as defined by stable utilization of inhaled steroids