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

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. Identifier: NCT02659618
Recruitment Status : Unknown
Verified September 2018 by Mary Tobin, Rush University Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : January 20, 2016
Last Update Posted : September 20, 2018
Genentech, Inc.
Information provided by (Responsible Party):
Mary Tobin, Rush University Medical Center

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
Severe Persistent Asthma

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
Study Start Date : April 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Primary Outcome Measures :
  1. Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC) [ Time Frame: Visit 1 day ]
  2. mRNA levels in severe asthmatics as analyzed by gene profiling analysis [ Time Frame: 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 [ Time Frame: Visit 1 day ]
  2. Serum samples will be collected and analyzed for measurement of total IgE [ Time Frame: Visit 1 day ]
    Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis

Biospecimen Retention:   Samples Without DNA
Venous blood and serum will be drawn and shipped to Genentech for analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thirty prospective subjects will be screened to identify 20 subjects with severe persistent asthma. These subjects will be recruited from the Allergy/Immunology outpatient clinic at Rush University Medical Center along with self-referral through advertising posted on campus.

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

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 identifier (NCT number): NCT02659618

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United States, Illinois
University Consultants in Allergy/Immunology
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Genentech, Inc.
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Responsible Party: Mary Tobin, Director, Rush University Medical Center Identifier: NCT02659618    
Other Study ID Numbers: ML29345
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Keywords provided by Mary Tobin, Rush University Medical Center:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases