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Elucidation of Acid-Induced Pulmonary Inflammation

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00361972
First received: August 8, 2006
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

We propose to study how heartburn may lead to different types of inflammation in one's airways. Additionally, we hope to 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 GER.


Condition Intervention Phase
Gastroesophageal Reflux
Asthma
 Drug: lansoprazole
Drug: placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Elucidation of Acid-Induced Pulmonary Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Asthma GERD Heartburn
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To determine whether treatment of asthmatics with gastric acid suppressing medication will decrease bronchial inflammation and bronchoreactivity in asthmatics. We will demonstrate a decrease in specific cytokine expression and inflammatory infiltrate in [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether reduction in inflammation in pulmonary biopsies (as defined by reduction in specific cytokines or cellular infiltrate) correlates with improvement in pulmonary symptoms as defined by use of rescue inhalers or validated asthma quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: lansoprazole
30 mg of placebo or lansoprazole twice daily for 2-4 months
Placebo Comparator: 2
placebo
 Drug: placebo
placebo comparator to lansoprazole, 30 mg, twice a day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. asthmatic
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361972

Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Kathryn Peterson, MD University of Utah
  More Information

No publications provided

Responsible Party: Kathryn A. Peterson, M.D., University of Utah HSC
ClinicalTrials.gov Identifier: NCT00361972     History of Changes
Other Study ID Numbers: 15444, IRB #15444
Study First Received: August 8, 2006
Last Updated: April 22, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Gastroesophageal Reflux
Inflammation
Pneumonia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Respiratory Tract Infections
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013