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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Mary Tobin, Rush University Medical Center

Tracking Information
First Submitted Date July 6, 2015
First Posted Date January 20, 2016
Last Update Posted Date September 20, 2018
Study Start Date April 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 19, 2016)
  • Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC) [ Time Frame: Visit 1 day ]
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 19, 2016)
  • 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 ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
Official Title Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Venous blood and serum will be drawn and shipped to Genentech for analysis.
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.
Condition Severe Persistent Asthma
Intervention Not Provided
Study Groups/Cohorts Severe Persistent Asthma
All subjects will have severe persistent asthma diagnosed by a doctor.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 19, 2016)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02659618
Other Study ID Numbers ML29345
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mary Tobin, Rush University Medical Center
Study Sponsor Rush University Medical Center
Collaborators Genentech, Inc.
Investigators Not Provided
PRS Account Rush University Medical Center
Verification Date September 2018