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

NCT ID: NCT02659618

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-12-16

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.

Conditions

Severe Persistent Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Severe Persistent Asthma

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

No interventions assigned to this group

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mary Tobin

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Consultants in Allergy/Immunology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

ML29345

Identifier Type: -

Identifier Source: org_study_id