Interaction Between Benralizumab and Basophils in Eosinophilic Asthma. Discovering a New Role of an Old Asthma Player: BASEAS STUDY (Basophils in Eosinophilic Asthma)

Status: Completed
Location: See location...
Intervention Type: Biological
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
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• .It is mandatory that all patients can comprehend the study requirements and provide informed consent for their participation in MEGA.

⁃ Group A:

• Adult people (≥ 18 and ≤ 80 years old) with eosinophilic severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without long-acting muscarinic antagonist or Montelukast or oral corticosteroids)

• Benralizumab treatment approved.

⁃ Group B:

⁃ .Patients with allergic asthma (prick test or RAST positive).

Locations
Other Locations
Spain
Instituto Investigación FJD
Madrid
Time Frame
Start Date: 2021-09-07
Completion Date: 2023-10-13
Participants
Target number of participants: 20
Treatments
BENRA Treated Patients
Patients with severe eosinophilic asthma who will be treated with benralizumab (Fasenra®, Astra Zeneca) will be able to participate in a volunteer manner in the study after sing informed consent.
Non BENRA TREATED PATIENTSP
patients with controlled severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without oral corticosteroids) but without request of benralizumab (Fasenra®, Astra Zeneca) treatment will be recruited
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

This content was sourced from clinicaltrials.gov