About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
University of Florence
Lead sponsor
GlaxoSmithKline
Collaborator