Elucidation of Acid-Induced Pulmonary Inflammation - Full Text View

Sponsor:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00361972

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 II Phase III

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

Drug Information available for: Lansoprazole

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

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Eligibility

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

Criteria

Inclusion Criteria:

asthmatic
Gastroesophageal reflux

Exclusion Criteria:

Severe asthmatics who have been hospitalized within the last 6 months or who have required oral steroid use within the last 4 weeks
Severe coronary artery disease
Cigarette/cigar smoking within the last 6 months
Documented allergies affecting the respiratory system
Subjects with contraindications to pH/impedance probe
1. Hemophilia
2. Septal deviation
Subjects with contraindications to bronchoscopy as outlined by the American Thoracic Society Guidelines
Anticoagulation
Pregnancy
Incarcerated patients
Current oral steroid use (may suppress levels of inflammation)
Upper respiratory infection within the last 2 weeks
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 February 12, 2012