Interaction Between Benralizumab and Basophils in Eosinophilic Asthma

Asthma; Eosinophilic Clinical Trial

— BASEAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742504
• Other study ID #: ESR-20-20764
• Status: Completed
• Start date: September 7, 2021
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 13, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• .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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• Asthma; Eosinophilic
• Pulmonary Eosinophilia

Intervention

Biological:
• BENRALIZUMAB
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).

Locations

Country	Name	City	State
Spain	Instituto Investigación FJD	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Fold changes of miRNAs profile in basophils	1. Fold changes of miRNAs profile in basophils after tratment of Benralizumab in in patients with severe eosinophilic asthma treatment.	From 6 to 18
Secondary	Fold changes of serum IL-5R	Fold changes of serum IL-5R (microg/ml) in patients treated with benralizumab	Fromm 6 to 12
Secondary	Effect of benralizumab in basophil apoptosis	The effect of benralizumab in basophil apoptosis isolated from from allergic asthmatic patients will be measure by fold change of annexin V	From 12 to 24 months
Secondary	Effect of benralizumab in KU812 apoptosis	The effect of benralizumab in KU812 apoptosis will be measure by fold change of annexin V in KU812 cultures	From 12 to 24 months
Secondary	Effect of benralizumab in basophil activation	The effect of benralizumab in basophil activation isolated from from allergic asthmatic patients will be measur by fold change of CD63, and CD203C on membrane by flow cytometry	From 12 to 24 months
Secondary	Effect of benralizumab in KU812 activation	The effect of benralizumab in KU812 activation will be measurie by fold change of CD63, and CD203C on membrane by flow cytometry	From 12 to 24 months
Secondary	Effect of benralizumab in basophil degranulation	The effect of benralizumab in basophil degranulation will be measure by histamine releasing in isolated basophils from from allergic asthmatic patients	From 12 to 24 months
Secondary	Effect of benralizumab in KU812 degranulation	The effect of benralizumab in basophil degranulation will be measure by histamine releasing in KU812 cultured cells	From 12 to 24 months