Eosinophil Subpopulations in Eosinophilic-associated Diseases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Florence

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

160 Participants
are grouped into 4 trial groups

Locations

This trial has no locations

Sponsors and collaborators

University of Florence

Lead sponsor

GlaxoSmithKline

Collaborator