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Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma

Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02659618
Collaborator
Genentech, Inc. (Industry)
20
Enrollment
1
Location
56.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the blood of patients with severe persistent asthma.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.

    Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
    Actual Study Start Date :
    Apr 1, 2016
    Actual Primary Completion Date :
    Sep 26, 2018
    Actual Study Completion Date :
    Dec 16, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Severe Persistent Asthma

    All subjects will have severe persistent asthma diagnosed by a doctor.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC) [Visit 1 day]

    2. mRNA levels in severe asthmatics as analyzed by gene profiling analysis [Visit 1 day]

      Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.

    Secondary Outcome Measures

    1. Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample [Visit 1 day]

    2. Serum samples will be collected and analyzed for measurement of total IgE [Visit 1 day]

      Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Physician diagnosis of severe persistent asthma;

    • Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;

    • Male or female age 12-65 years;

    • Non-smoker.

    Exclusion Criteria:

    • Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;

    • Respiratory infection within 30 days prior to the study;

    • Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;

    • Having been treated with Xolair within the past year;

    • Requiring chronic immunosuppressive therapy;

    • Having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study;

    • Having taken an investigational drug within 30 days prior to the study;

    • Have a history of drug or alcohol abuse;

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Consultants in Allergy/Immunology Chicago Illinois United States 60612

    Sponsors and Collaborators

    • Rush University Medical Center
    • Genentech, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mary Tobin, Director, Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02659618
    Other Study ID Numbers:
    • ML29345
    First Posted:
    Jan 20, 2016
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Dec 1, 2020
    Keywords provided by Mary Tobin, Director, Rush University Medical Center
    Asthma
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Feb 11, 2022