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.
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.
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
Each subject should meet all of the inclusion criteria and none of the exclusion criteria for this study. Under no circumstances can there be exceptions to this rule.
Case-control
Prospective
Not listed
Primary objective: first outcome measure
1\) Proportion of circulating Siglec8+CD16-CD62Llow (iEos) and Siglec8+CD16-CD62Lbright (rEos) cells in bio- naïve, EGPA and HES patients
Primary objective: second outcome measure
2\) Modification of the expression of CD62L on peripheral eosinophils upon in vitro stimulation with IL-5, IL-3, GM-CSF, IL-4, IL-13
Secondary objective: first outcome measure
1\) Proportion of circulating Siglec8+CD16-CD62Llow (iEos) cells in bio-naïve EA, EGPA, and HES patients
Secondary objective: second outcome measure
2\) Correlation between Siglec8+CD16-CD62Llow (iEos) cells and disease-specific clinical scores in bio-naïve EGPA, HES and EA patients
Explorative objective
1\) Modification of the proportion of CD62Llow and CD62Lbright among eosinophils obtained from EGPA and HES patients, upon in vitro coculture with mepolizumab and type 2 cytokines.
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University of Florence
Lead sponsor
GlaxoSmithKline
Collaborator
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