Instituto Investigación FJD
Madrid, Spain
NCT Number: NCT04742504
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
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Notify Me18 year–80 year
All sexes
Observational
Madrid, Spain
For this:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group A:
Group B:
.Patients with allergic asthma (prick test or RAST positive).
Exclusion criteria
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).
Time frame: From 1 to 12 months
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
Time frame: From 1 to 12 months
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
Time frame: From 1 to 12 months
The fold changes of IL-5R expression in basophils after 8 week, 6 months and 1 year of benralizumab treatmen
Time frame: From 1 to 12 months
The fold changes of f IL-5R expression in innate lymphoid cells after 8 week, 6 months and 1 year of benralizumab treatment
Time frame: From 6 to 18
Time frame: Fromm 6 to 12
Fold changes of serum IL-5R (microg/ml) in patients treated with benralizumab
Time frame: From 12 to 24 months
The effect of benralizumab in basophil apoptosis isolated from from allergic asthmatic patients will be measure by fold change of annexin V
Time frame: From 12 to 24 months
The effect of benralizumab in KU812 apoptosis will be measure by fold change of annexin V in KU812 cultures
Time frame: From 12 to 24 months
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
Time frame: From 12 to 24 months
The effect of benralizumab in KU812 activation will be measurie by fold change of CD63, and CD203C on membrane by flow cytometry
Time frame: From 12 to 24 months
The effect of benralizumab in basophil degranulation will be measure by histamine releasing in isolated basophils from from allergic asthmatic patients
Time frame: From 12 to 24 months
The effect of benralizumab in basophil degranulation will be measure by histamine releasing in KU812 cultured cells
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Other
Interaction Between Benralizumab and Basophils in Eosinophilic Asthma. Discovering a New Role of an Old Asthma Player: BASEAS STUDY (Basophils in Eosinophilic Asthma)
Acronym: BASEAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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