Eosinophil Subpopulations in Eosinophilic-associated Diseases

Launched by UNIVERSITY OF FLORENCE · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Eosinophil Subpopulations in Eosinophilic-associated Diseases," aims to better understand certain types of white blood cells called eosinophils in patients with eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). The study will involve 160 participants, including 80 with eosinophilic asthma, 30 with EGPA, 25 with HES, and 25 healthy donors. Researchers will look at different eosinophil groups in these diseases and how they relate to the severity of the conditions. The study will last from late 2024 to late 2026.

To be eligible for this study, participants must be adults aged 18 to 75 who have one of the eosinophilic conditions mentioned above, with specific blood tests confirming their diagnosis. Healthy donors should also be within the same age range. Participants can expect to provide consent and undergo tests to analyze their eosinophil levels and response to a medication called mepolizumab. This trial is important because it may help improve our understanding of these diseases and how to treat them more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• - For inclusion in the study subjects should fulfill the following criteria based on local regulations:
• Patients with Asthma, or EGPA or HES:
• • 1. Age between 18 and 75 years at the time of signing the informed consent
• • 2. Patients with EA, EGPA or HES
• • 3. 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
• Exclusion Criteria:
• * Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
• • 1. Presence of other chronic pulmonary diseases including COPD
• • 2. Presence of other chronic immuno-mediated inflammatory diseases
• • 3. Treatment with oral prednisone or equivalent \> 7.5 mg/day
• • 4. Treatment with long-acting depot corticosteroids in the last three months
• • 5. Use of immunosuppressive medications (cyclosporine A; azathioprine; methotrexate; mycophenolate mofetil)
• • 6. Receipt of live attenuated vaccines 30 days prior to the enrollment
• • 7. Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
• • 8. 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
• • 9. Subjects who are pregnant or breastfeeding
• • 10. Current smoking
• • 11. 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.
• • 12. Concurrent enrolment in another interventional or post-authorization safety study.