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Clinical Trial Summary

In this study, investigators want to evaluation of the impact of benralizumab (Fasenra®, Astra Zeneca) on different cell populations, including basophils and innate lymphoid cells, and several biomarkers, such as miRNAs, cadena α dek receptor pra la interleukin % (IL5Rα) and soluble IL5Rα in patients with severe eosinophilic asthma. For this, basophil and innate cells type 2 (ILC2) populations will be monitored in different point-time of treatment: 8 week (V1), 6 months (V2) and 1 year (V3) in blood and sputum samples. Also, follow-up IL5Rα expression on a cell surface of eosinophils, basophils and ILC2 from peripheral blood and sputum of patients treated with or or without benralizumab. Determination of IL5Rα levels will be performed by flow cytometry


Clinical Trial Description

For this: 1. Investigators will monitor basophil miRNAs changes with benralizumab analyzing miRNAS profile of isolated basophil before and after benralizumab treatment. 2. Also, in vitro characterization of benralizumab effects on functionality of human basophils (isolated from allergic asthmatic patients) and human cell line KU812, measuring apoptosis, activation, degranulation and histamine release will be performed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04742504
Study type Observational
Source Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact
Status Completed
Phase
Start date September 7, 2021
Completion date October 13, 2023

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