Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04742504
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interaction Between Benralizumab and Basophils in Eosinophilic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011657', 'term': 'Pulmonary Eosinophilia'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571386', 'term': 'benralizumab'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fold changes in number of basophils', 'timeFrame': 'From 1 to 12 months', 'description': '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'}, {'measure': 'Fold changes in number of innate inmmune cells', 'timeFrame': 'From 1 to 12 months', 'description': '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'}, {'measure': 'The fold changes of IL-5R expression in basophils', 'timeFrame': 'From 1 to 12 months', 'description': 'The fold changes of IL-5R expression in basophils after 8 week, 6 months and 1 year of benralizumab treatmen'}, {'measure': 'The fold changes of f IL-5R expression in innate lymphoid cells', 'timeFrame': 'From 1 to 12 months', 'description': 'The fold changes of f IL-5R expression in innate lymphoid cells after 8 week, 6 months and 1 year of benralizumab treatment'}], 'secondaryOutcomes': [{'measure': 'Fold changes of miRNAs profile in basophils', 'timeFrame': 'From 6 to 18', 'description': '1\\. Fold changes of miRNAs profile in basophils after tratment of Benralizumab in in patients with severe eosinophilic asthma treatment.'}, {'measure': 'Fold changes of serum IL-5R', 'timeFrame': 'Fromm 6 to 12', 'description': 'Fold changes of serum IL-5R (microg/ml) in patients treated with benralizumab'}, {'measure': 'Effect of benralizumab in basophil apoptosis', 'timeFrame': 'From 12 to 24 months', 'description': 'The effect of benralizumab in basophil apoptosis isolated from from allergic asthmatic patients will be measure by fold change of annexin V'}, {'measure': 'Effect of benralizumab in KU812 apoptosis', 'timeFrame': 'From 12 to 24 months', 'description': 'The effect of benralizumab in KU812 apoptosis will be measure by fold change of annexin V in KU812 cultures'}, {'measure': 'Effect of benralizumab in basophil activation', 'timeFrame': 'From 12 to 24 months', 'description': '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'}, {'measure': 'Effect of benralizumab in KU812 activation', 'timeFrame': 'From 12 to 24 months', 'description': 'The effect of benralizumab in KU812 activation will be measurie by fold change of CD63, and CD203C on membrane by flow cytometry'}, {'measure': 'Effect of benralizumab in basophil degranulation', 'timeFrame': 'From 12 to 24 months', 'description': 'The effect of benralizumab in basophil degranulation will be measure by histamine releasing in isolated basophils from from allergic asthmatic patients'}, {'measure': 'Effect of benralizumab in KU812 degranulation', 'timeFrame': 'From 12 to 24 months', 'description': 'The effect of benralizumab in basophil degranulation will be measure by histamine releasing in KU812 cultured cells'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Basophils', 'anti-receptor de interleukin 5', 'microRNAs', 'Benralizumab'], 'conditions': ['Asthma; Eosinophilic']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'For this:\n\n1. Investigators will monitor basophil miRNAs changes with benralizumab analyzing miRNAS profile of isolated basophil before and after benralizumab treatment.\n2. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).\n\nGroup B:patients with allergic asthma without indication of treatment with biological therapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* .It is mandatory that all patients can comprehend the study requirements and provide informed consent for their participation in MEGA.\n\nGroup A:\n\n* 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)\n* Benralizumab treatment approved.\n\nGroup B:\n\n.Patients with allergic asthma (prick test or RAST positive).\n\nExclusion Criteria:\n\n* Patients with continuous OCS treatment\n* Patients with Immunosuppressive drugs\n* Patients with primary or secondary immune deficiency,\n* Patients with chronic or/and concomitant disease, presence of severe systemic disease or cancer,\n* Patients with possible infestation by parasites.\n* Patients with other acute or chronic active lung disorders Patients with significant psychiatric disorders\n* Patients with biological treatment will be excludes for group B'}, 'identificationModule': {'nctId': 'NCT04742504', 'acronym': 'BASEAS', 'briefTitle': 'Interaction Between Benralizumab and Basophils in Eosinophilic Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Interaction Between Benralizumab and Basophils in Eosinophilic Asthma. Discovering a New Role of an Old Asthma Player: BASEAS STUDY (Basophils in Eosinophilic Asthma)', 'orgStudyIdInfo': {'id': 'ESR-20-20764'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BENRA Treated Patients', 'description': '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.', 'interventionNames': ['Biological: BENRALIZUMAB']}, {'label': 'Non BENRA TREATED PATIENTSP', 'description': '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': [{'name': 'BENRALIZUMAB', 'type': 'BIOLOGICAL', 'description': '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).', 'armGroupLabels': ['BENRA Treated Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Instituto Investigación FJD', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'VICTORIA DEL POZO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IIS-FUNDACIÓN JIMENEZ DIAZ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}