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Elucidation of Acid-Induced Pulmonary Inflammation

This study has been terminated.
(limited recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361972
First Posted: August 9, 2006
Last Update Posted: August 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kathryn A. Peterson, University of Utah
  Purpose
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).

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

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

Resource links provided by NLM:


Further study details as provided by Kathryn A. Peterson, University of Utah:

Primary Outcome Measures:
  • Change in Lymphocyte Count [ Time Frame: Baseline and 6 weeks ]
    Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.


Secondary Outcome Measures:
  • Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement [ Time Frame: Baseline and 6 weeks ]
    Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.


Enrollment: 17
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: Lansoprazole therapy
Lansoprazole 30 mg orally twice daily
Drug: lansoprazole
30 mg of lansoprazole twice daily for 6 weeks
Other Name: Prevacid
Placebo Comparator: Placebo
placebo orally twice daily
Drug: placebo
placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kathryn A. Peterson, md, University of Utah
ClinicalTrials.gov Identifier: NCT00361972     History of Changes
Other Study ID Numbers: 15444
IRB #15444
First Submitted: August 8, 2006
First Posted: August 9, 2006
Results First Submitted: January 14, 2016
Results First Posted: August 5, 2016
Last Update Posted: August 5, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Gastroesophageal Reflux
Pneumonia
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action