Status:
NOT_YET_RECRUITING
Eosinophil Subpopulations in Eosinophilic-associated Diseases
Lead Sponsor:
University of Florence
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Eosinophilic Asthma
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Eligibility:
All Genders
18-75 years
Brief Summary
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 syndro...
Detailed Description
Introduction Eosinophils (Eos) play a crucial role in both normal physiological functions and various pathological conditions. They are primarily recognized for their involvement in immune defense aga...
Eligibility Criteria
Inclusion
- \- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06911775
Start Date
April 1 2025
End Date
December 1 2026
Last Update
April 4 2025
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