Elucidation of Acid-Induced Pulmonary Inflammation

NCT00361972 | Terminated Phase 2 Results

• 2 other identifiers: 15444IRB #15444
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastroesophageal Reflux; Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Lymphocyte Count

  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.

  Baseline and 6 weeks

Secondary Outcomes (1)

• Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement

  Baseline and 6 weeks

Study Arms (2)

Lansoprazole therapy

ACTIVE COMPARATOR

Lansoprazole 30 mg orally twice daily

Drug: lansoprazole

Placebo

PLACEBO COMPARATOR

placebo orally twice daily

Drug: placebo

Interventions

lansoprazole DRUG

30 mg of lansoprazole twice daily for 6 weeks

Also known as: Prevacid

Lansoprazole therapy

placebo DRUG

placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic cough consistent with bronchoreactivity
• Gastroesophageal reflux

You may not qualify if:

• 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
• Hemophilia
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Asthma

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Questionnaires were not assessed as many of them were incomplete. Drop out occurred due to incomplete tissues Early termination: the total number of participants could not be enrolled in a timely manner..

Results Point of Contact

• Title: kathryn peterson
• Organization: university of utah

kathryn.peterson@hsc.utah.edu

8015817804

Study Officials

• Kathryn Peterson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 9, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 5, 2016
• Results First Posted: August 5, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)