Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02659618
Other study ID # ML29345
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date December 16, 2020

Study information

Verified date December 2020
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 16, 2020
Est. primary completion date September 26, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University Consultants in Allergy/Immunology Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Rush University Medical Center Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC) Visit 1 day
Primary mRNA levels in severe asthmatics as analyzed by gene profiling analysis Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins. Visit 1 day
Secondary Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample Visit 1 day
Secondary Serum samples will be collected and analyzed for measurement of total IgE Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis Visit 1 day
See also
  Status Clinical Trial Phase
Terminated NCT01197482 - Inhaled Steroids and Control of Severe Asthma
Withdrawn NCT02952066 - Expressions of TRPV1 in Airway of Asthmatics N/A
Completed NCT02559791 - Anti-Interleukin-5 (IL5) Monoclonal Antibody (MAb) in Prednisone-dependent Eosinophilic Asthma Phase 2/Phase 3
Recruiting NCT03617718 - Project 2 Airway Potential Hydrogen (pH) in Asthma Phase 1/Phase 2
Recruiting NCT01839591 - Bronchial Thermoplasty: Effect on Neuronal and Chemosensitive Component of the Bronchial Mucosa N/A
Withdrawn NCT00954850 - A National Program for Severe Asthma: The Canadian Severe Asthma Network N/A
Completed NCT01748175 - Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma
Withdrawn NCT01745809 - Bronchoscopy Study for Severe Asthma N/A
Completed NCT02717689 - A Pragmatic Trial of Corticosteroid Optimisation in Severe Asthma N/A
Completed NCT01750411 - Severe Asthma Research Program - Wake Forest University
Completed NCT01862289 - Prevalence of Hyperventilation Syndrome in Difficult Asthma N/A
Withdrawn NCT00689806 - Evaluation of Lovastatin in Severe Persistent Asthma Phase 1/Phase 2