NCT06911775Not yet recruiting
Eosinophil Subpopulations in Eosinophilic-associated Diseases
Exploring Inflammatory and Regulatory Eosinophil Subpopulations: the Path to Precision Medicine for the Treatment of Eosinophilic-associated Diseases
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- Apr 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- University of Florence
- Diseases
- Asthma, ANCA-associated vasculitis
- NCT number
- NCT06911775
What you commit to
- Study type: Observational
- Planned participants: 160
- From Apr 2025 to the primary completion date, Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- 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.
- 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
- Subjects who are pregnant or breastfeeding
- Current smoking
- Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the investigator may put the patient at risk of his/her participation in the study, or may influence the results of the study, or the patient\'s ability to complete entire duration of the study.
- Concurrent enrolment in another interventional or post-authorization safety study.
Who the study is looking for
- \- For inclusion in the study subjects should fulfill the following criteria based on local regulations:
- Patients with Asthma, or EGPA or HES:
- 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.
- Healthy donors:
- 1\. Age between18 and 75 years healthy donors
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.