Elucidation of Acid-Induced Pulmonary Inflammation - Full Text View

Sponsored by:	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

MedlinePlus related topics: Asthma GERD Heartburn

Drug Information available for: Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Elucidation of Acid-Induced Pulmonary Inflammation

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 ]

Estimated Enrollment:	30
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: lansoprazole 30 mg of placebo or lansoprazole twice daily for 2-4 months
2: Placebo Comparator 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:

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

Contacts

Contact: Kristen L Thomas, BS	801-587-9854	kristen.thomas@hsc.utah.edu
Contact: Kristen Hilden, MS	801-581-3693	kristen.thomas@hsc.utah.edu

Locations

United States, Utah
University of Utah Health Sciences Center	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kristen L Thomas, BS 801-587-9854 kristen.thomas@hsc.utah.edu
Contact: kristen Hilden, MS 801-581-3693 kristen.hilden@hsc.utah.edu
Principal Investigator: Kathryn A Peterson, MD, MSci
Sub-Investigator: Mae Go, MD
Sub-Investigator: David Young, PharmD
Sub-Investigator: Wayne Samuelson, MD

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Kathryn Peterson, MD

University of Utah

More Information

Responsible Party:	University of Utah HSC ( Kathryn A. Peterson, M.D. )
Study ID Numbers:	15444, IRB #15444
Study First Received:	August 8, 2006
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00361972
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Esophageal disorder
Gastrointestinal Diseases
Asthma
Gastroesophageal Reflux
Inflammation
Esophageal Motility Disorders
Deglutition Disorders

Digestive System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Lansoprazole
Esophageal Diseases
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009