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

NCT02659618 | Completed

• 1 other identifier: ML29345
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Persistent Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (2)

• Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)

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• mRNA levels in severe asthmatics as analyzed by gene profiling analysis

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

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Secondary Outcomes (2)

• Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample

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• Serum samples will be collected and analyzed for measurement of total IgE

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Study Arms (1)

Severe Persistent Asthma

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

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University Consultants in Allergy/Immunology

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood and serum will be drawn and shipped to Genentech for analysis.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: January 20, 2016
• Study Start: April 1, 2016
• Primary Completion: September 26, 2018
• Study Completion: December 16, 2020
• Last Updated: February 11, 2022

Record last verified: 2020-12

Locations

US (1)