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 range18 Years – 75 Years
SexALL
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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
✕. 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.
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
✕. 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