Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
|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
|Condition or disease|
|Severe Persistent Asthma|
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|
|Estimated Enrollment :||30 participants|
|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|
Severe Persistent Asthma
All subjects will have severe persistent asthma diagnosed by a doctor.
- 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.
- 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
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659618
|United States, Illinois|
|University Consultants in Allergy/Immunology|
|Chicago, Illinois, United States, 60612|