Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT07159295
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2025-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab', 'timeFrame': 'Baseline/Index date', 'description': 'Demographic: Gender, age, BMI, smoking history Clinical: age of asthma diagnosis, ACT score, CARAT score, blood eosinophil count, FeNO, Lung function, FVC, Reversibility of FEV1, Total IgE in peripheral blood, Skin PRICK test'}, {'measure': 'Background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation and treatment duration with benralizumab', 'timeFrame': 'Baseline, 3, 6, 12 and 24 months', 'description': 'Medication history: asthma treatment type, doses and treatment duration Proportion of patients with biologic discontinued and reason for discontinuation Benralizumab treatment patterns: benralizumab treatment duration, frequency of benralizumab treatment discontinuation, time to treatment discontinuation and frequency and type of concurrent respiratory medication'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients', 'timeFrame': 'Baseline, 3, 6, 12 and 24 months', 'description': 'Frequency of asthma exacerbations, annual rate of severe exacerbation, mean change in lung function (FEV1), FVC, reversibility of FEV1, blood eosinophil count, FeNO, Total IgE in peripheral blood, CARAT and ACT scores, proportion of patients achieving an improvement in CARAT ACT, percentage of patients with OCS ≤5mg/day, percentage change in daily OCS dose, percentage of patients experiencing reduction daily OCS use from index date by \\>0%, ≥25%, ≥50%, ≥75%, ≥90% and 100%'}, {'measure': 'Asthma-related Healthcare resource utilization (HCRU) among severe eosinophilic asthma patients before and after initiation of benralizumab therapy', 'timeFrame': 'Baseline, 3, 6, 12 and 24 months', 'description': 'Number of emergency room visits, Number of schedule medical visits for asthma, Number of unscheduled medical visits for asthma, Number of hospitalizations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250R00088&attachmentIdentifier=1aa77882-f9af-4dfc-92f4-f8cc413a6053&fileName=D3250R00088_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'D3250R00088\\_CSR Synopsis\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'Benralizumab is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β2-agonists. It has been reimbursed in Portugal as an add-on therapy since May 2019. In order of this, there is crucial need in Portugal to provide key real-word evidence on benralizumab therapy.', 'detailedDescription': 'This is a real-world retrospective, multicentric, observational study, utilizing secondary data collection from medical records of adults patients (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who, at the discretion of the physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Severe eosinophilic asthma patients aged 18 and above, treated with benralizumab and who have had their first benralizumab dose between July 2019 and October 2020 and who have at least 1 benralizumab injection and with at least 3 months follow-up data from the first injection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients with severe asthma treated with benralizumab, who had their first benralizumab dose between July 2019 and October 2020\n\n * Patients who have at least 1 benralizumab injection and with at least 3 months follow-up data from the first injection.\n * Give voluntary signed informed consent\n\nExclusion Criteria:\n\n* Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial'}, 'identificationModule': {'nctId': 'NCT07159295', 'acronym': 'Betreat', 'briefTitle': 'Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Betreat (Xaloc1) Benralizumab Study: Retrospective, Observational Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes', 'orgStudyIdInfo': {'id': 'D3250R00088'}}, 'contactsLocationsModule': {'locations': [{'zip': '2720-276', 'city': 'Amadora', 'country': 'Portugal', 'facility': 'Hospital Prof. Dr. Fernando Fonseca', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '4750-275', 'city': 'Barcelos', 'country': 'Portugal', 'facility': 'HSMM', 'geoPoint': {'lat': 41.53174, 'lon': -8.61843}}, {'zip': '3000 -076', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CHUC - Imunoalergologia', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '3000 -076', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CHUC - Pneumologia', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '8000-368', 'city': 'Faro', 'country': 'Portugal', 'facility': 'CHUA', 'geoPoint': {'lat': 37.01869, 'lon': -7.92716}}, {'zip': '2410-197', 'city': 'Leiria', 'country': 'Portugal', 'facility': 'Hospital Leiria', 'geoPoint': {'lat': 39.74362, 'lon': -8.80705}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Chln - Hsm', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Chuln - Hsm', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4464-513', 'city': 'Matosinhos Municipality', 'country': 'Portugal', 'facility': 'Hospital Pedro Hispano', 'geoPoint': {'lat': 41.18207, 'lon': -8.68908}}, {'zip': '8500-338', 'city': 'Portimão', 'country': 'Portugal', 'facility': 'CHUA', 'geoPoint': {'lat': 37.13856, 'lon': -8.53775}}, {'zip': '4200 - 319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'CHUSJ - Imuno', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4200 - 319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'CHUSJ - Pneumo', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Chusj - Cri', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '2005-177', 'city': 'Santarém', 'country': 'Portugal', 'facility': 'Hospital Distrital de Santarém', 'geoPoint': {'lat': 39.23379, 'lon': -8.68617}}, {'zip': '4430 - 999', 'city': 'Vila Nova de Gaia', 'country': 'Portugal', 'facility': 'CHVNGE', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '5000-508', 'city': 'Vila Real', 'country': 'Portugal', 'facility': 'CHTMAD', 'geoPoint': {'lat': 41.3001, 'lon': -7.7432}}], 'overallOfficials': [{'name': 'Rosa Fernandes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Pedro Hispano'}, {'name': 'Claudia Loureiro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUC Pneumo'}, {'name': 'Carlos Loureiro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUC Imuno'}, {'name': 'Ulisses Brito', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUA - Faro'}, {'name': 'Inês Belchior', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUA - Portimão'}, {'name': 'Ana Mendes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHLN- HSM - Imuno'}, {'name': 'Gonçalo Portugal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHLN - HSM - Pneumo'}, {'name': 'Rita Boaventura', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital S. João- Pneumo'}, {'name': 'José Plácido', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital S. João - Imuno'}, {'name': 'Cecília Pardal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Prof. Dr. Fernando Fonseca'}, {'name': 'Gustavo Reis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Distrital de Santarém'}, {'name': 'Ricardo Lima', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHVNGE'}, {'name': 'Liliana Ribeiro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro'}, {'name': 'Nuno Pires', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HSMM- Barcelos'}, {'name': 'Nuno Sousa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Leiria'}, {'name': 'Filipa Carriço', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital São João - CRI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD is planned to be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}