CompletedNot Applicable

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

United States20 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range

12 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Visit 1 day

mRNA levels in severe asthmatics as analyzed by gene profiling analysis

Timeframe: Visit 1 day

Trial details

NCT IDNCT02659618

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-09-26

View on ClinicalTrials.gov More Severe Persistent Asthma trials

Who can participate

Age range

12 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.