Clinical trial NCT04742504: Interaction Between Benralizumab and Basophils in Eosinophilic Asthma
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma; Eosinophilic
Keywords: Asthma
Basophils
anti-receptor de interleukin 5
microRNAs
Benralizumab
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fold changes in number of basophils
timeFrame: From 1 to 12 months
measure: Fold changes in number of innate inmmune cells
timeFrame: From 1 to 12 months
measure: The fold changes of IL-5R expression in basophils
timeFrame: From 1 to 12 months
measure: The fold changes of f IL-5R expression in innate lymphoid cells
timeFrame: From 1 to 12 months
Secondary outcomes:
measure: Fold changes of miRNAs profile in basophils
timeFrame: From 6 to 18
measure: Fold changes of serum IL-5R
timeFrame: Fromm 6 to 12
measure: Effect of benralizumab in basophil apoptosis
timeFrame: From 12 to 24 months
measure: Effect of benralizumab in KU812 apoptosis
timeFrame: From 12 to 24 months
measure: Effect of benralizumab in basophil activation
timeFrame: From 12 to 24 months
measure: Effect of benralizumab in KU812 activation
timeFrame: From 12 to 24 months
measure: Effect of benralizumab in basophil degranulation
timeFrame: From 12 to 24 months
measure: Effect of benralizumab in KU812 degranulation
timeFrame: From 12 to 24 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Investigación FJD
Study officials:
affiliation: IIS-FUNDACIÓN JIMENEZ DIAZ
name: VICTORIA DEL POZO, PhD
role: PRINCIPAL_INVESTIGATOR
References: