Interaction Between Benralizumab and Basophils in Eosinophilic Asthma

NCT04742504 | Completed

• 1 other identifier: ESR-20-20764
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Asthma; Eosinophilic

Keywords

Asthma; Basophils; anti-receptor de interleukin 5; microRNAs; Benralizumab

Outcome Measures

Primary Outcomes (4)

• Fold changes in number of basophils

  Fold changes in number of basophils after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma

  From 1 to 12 months

• Fold changes in number of innate inmmune cells

  Fold changes in number of innate immune cells s after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma

  From 1 to 12 months

• The fold changes of IL-5R expression in basophils

  The fold changes of IL-5R expression in basophils after 8 week, 6 months and 1 year of benralizumab treatmen

  From 1 to 12 months

• The fold changes of f IL-5R expression in innate lymphoid cells

  The fold changes of f IL-5R expression in innate lymphoid cells after 8 week, 6 months and 1 year of benralizumab treatment

  From 1 to 12 months

Secondary Outcomes (8)

• Fold changes of miRNAs profile in basophils

  From 6 to 18

• Fold changes of serum IL-5R

  Fromm 6 to 12

• Effect of benralizumab in basophil apoptosis

  From 12 to 24 months

• Effect of benralizumab in KU812 apoptosis

  From 12 to 24 months

• Effect of benralizumab in basophil activation

  From 12 to 24 months

Study Arms (2)

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.

Biological: BENRALIZUMAB

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

Interventions

BENRALIZUMAB BIOLOGICAL

The decision of the patients treatment with benralizumab (Fasenra®, Astra Zeneca) included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA).

BENRA Treated Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group A: f patients with severe eosinophilic uncontrolled asthma treated with Benralizumab Those will be patients with severe eosinophilic asthma who are being treated with benralizumab and who want to participate in a volunteer manner in the study after signing informed consent. The decision of the patients treatment with benralizumab included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA). Group B:patients with allergic asthma without indication of treatment with biological therapy.

You may qualify if:

• 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).

You may not qualify if:

• Patients with continuous OCS treatment
• Patients with Immunosuppressive drugs
• Patients with primary or secondary immune deficiency,
• Patients with chronic or/and concomitant disease, presence of severe systemic disease or cancer,
• Patients with possible infestation by parasites.
• Patients with other acute or chronic active lung disorders Patients with significant psychiatric disorders
• Patients with biological treatment will be excludes for group B

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Instituto Investigación FJD

Madrid, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, sputum

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• VICTORIA DEL POZO, PhD

  IIS-FUNDACIÓN JIMENEZ DIAZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: February 8, 2021
• Study Start: September 7, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 13, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

ES (1)