Eosinophil Subpopulations in Eosinophilic-associated Diseases (NCT06911775) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Eosinophil Subpopulations in Eosinophilic-associated Diseases
160 participantsStarted 2025-04
Plain-language summary
This single-center, non-commercial study will involve 160 participants (80 with eosinophilic asthma (EA), 30 with eosinophilic granulomatosis with polyangiitis (EGPA), 25 with hypereosinophilic syndrome (HES), and 25 healthy donors) to investigate eosinophil subpopulations in these diseases. The study will run from Q4 2024 to Q4 2026.
Objectives:
Primary: To verify two eosinophil subpopulations (iEos and rEos) in EGPA and HES and analyze the role of type 2 cytokines on their plasticity.
Secondary: Compare iEos proportion between different eosinophilic diseases and correlate with disease severity.
Exploratory: Assess the effect of mepolizumab on eosinophil subpopulations in vitro.
Population: Adults aged 18-75 with EA, EGPA, or HES, and healthy controls. EA patients must have \>300 eosinophils/mcL, EGPA requires asthma + eosinophilia + other specific features, and HES requires high eosinophil counts (\>1500 cells/mL).
Methods: Data will be analyzed using Mann-Whitney U, ANOVA, and Spearman correlation tests, with results presented as mean ± SEM.
This study will help explore eosinophil behavior in eosinophilic diseases and evaluate mepolizumab's effects on these cells.
Who can participate
Age range
18 Years – 75 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
. Age between 18 and 75 years at the time of signing the informed consent
. Patients with EA, EGPA or HES
. Provision of signed and dated written informed consent form prior to any mandatory study procedures, sampling and analysis.
Exclusion criteria
. Presence of other chronic pulmonary diseases including COPD
. Presence of other chronic immuno-mediated inflammatory diseases
. Treatment with oral prednisone or equivalent \> 7.5 mg/day
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
1
Primary objective: first outcome measure
Timeframe: From the enrollment of the first patient at 20 months
2
Primary objective: second outcome measure
Timeframe: From the enrollment of the first patient at 20 months
. Treatment with long-acting depot corticosteroids in the last three months
. Use of immunosuppressive medications (cyclosporine A; azathioprine; methotrexate; mycophenolate mofetil)
. Receipt of live attenuated vaccines 30 days prior to the enrollment
. Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy