Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-02 @ 1:44 AM
Study NCT ID:
NCT06456450
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taiwan Severe Asthma Biologic Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract 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': 'D000069444', 'term': 'Omalizumab'}, {'id': 'C434107', 'term': 'mepolizumab'}, {'id': 'C571386', 'term': 'benralizumab'}, {'id': 'C000622721', 'term': 'tezepelumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2043-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2043-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Status of Asthma Control', 'timeFrame': '6 months', 'description': 'Mean change in Asthma Control Test score after biologic initiation.'}, {'measure': 'Status of Asthma exacerbations', 'timeFrame': '6 months', 'description': 'Annual frequency of exacerbations after biologic initiation.'}, {'measure': 'Reduction of daily oral corticosteriod dose', 'timeFrame': '6 months', 'description': 'Percentage of daily oral corticosteroids dose reduction after biologic initiation.'}, {'measure': 'Change of Pre-BD FEV1 (%pred)', 'timeFrame': '6 months', 'description': 'Measure the change of Pre-BD FEV1 (%pred) after biologic initiation. FVC (L) FEV1(L)'}], 'secondaryOutcomes': [{'measure': 'Disease Prognosis', 'timeFrame': '6 months', 'description': '1. Describe the Cross-sectional phenotypic or pathophysiological (endotype) characteristics of poor asthma control.\n2. Describe the natural history, intervention responsiveness and long-term prognosis of severe asthma.'}, {'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'Define the mortality rate of the study cohort'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Asthma', 'Registry', 'Biologic'], 'conditions': ['Pulmonary Disease', 'Asthma']}, 'descriptionModule': {'briefSummary': 'This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan.\n\nThe goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. Determine risk factors associated with poor asthma control.\n2. Support the development of effectiveness and safety of therapeutic principles\n3. To discover the real-world effectiveness of different biologics ( Clinical remission)\n4. To discover the impact of initiating biologics for severe asthma patients.\n5. To evaluate the prevalence of biologics switching and its benefits for patients.\n6. To compare the achievement rate of clinical remission among different biologics.\n\nParticipants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe Asthma Patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures.\n* Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case.\n* Female and male aged over 18 years old.\n* Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020.\n\nExclusion Criteria:\n\n* Lack of informed consent for participation.\n* History of Biologic usage before January 1, 2020, should be ruled out.\n* The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation.\n* Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma.'}, 'identificationModule': {'nctId': 'NCT06456450', 'acronym': 'TARGET', 'briefTitle': 'Taiwan Severe Asthma Biologic Registry', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Taiwan Severe Asthma Biologic Registry', 'orgStudyIdInfo': {'id': 'CE24049B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Omalizumab', 'description': 'Severe asthma patients who are treated with omalizumab after January 1, 2020.', 'interventionNames': ['Biological: Biological Treatment for severe asthma patients']}, {'label': 'Mepolizumab', 'description': 'Severe asthma patients who are treated with mepolizumab after January 1, 2020.', 'interventionNames': ['Biological: Biological Treatment for severe asthma patients']}, {'label': 'Benralizumab', 'description': 'Severe asthma patients who are treated with benralizumab after January 1, 2020.', 'interventionNames': ['Biological: Biological Treatment for severe asthma patients']}, {'label': 'Dupilzumab', 'description': 'Severe asthma patients who are treated with dupilzumab after January 1, 2020.', 'interventionNames': ['Biological: Biological Treatment for severe asthma patients']}, {'label': 'Tezepelumab', 'description': 'Severe asthma patients who are treated with Tezepelumab after January 1, 2020.', 'interventionNames': ['Biological: Biological Treatment for severe asthma patients']}], 'interventions': [{'name': 'Biological Treatment for severe asthma patients', 'type': 'BIOLOGICAL', 'otherNames': ['Omalizumab', 'Mepolizumab', 'Benralizumab', 'Dupilzumab', 'Tezepelumab'], 'description': 'Biological treatment for severe asthma available in Taiwan and is covered by covered by National Health Insurance', 'armGroupLabels': ['Benralizumab', 'Dupilzumab', 'Mepolizumab', 'Omalizumab', 'Tezepelumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pin-Kuei Fu, MD, PhD', 'role': 'CONTACT', 'email': 'yetquen@gmail.com', 'phone': '886-4-23592525', 'phoneExt': '3213'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Pin-Kuei Fu, MD.,PhD.', 'role': 'CONTACT', 'email': 'yetquen@gmail.com', 'phone': '886-4-23592525', 'phoneExt': '6535'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'E-DA Hospital', 'class': 'OTHER'}, {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, {'name': 'National Yang Ming Chiao Tung University Hospital', 'class': 'OTHER'}, {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Trail Center', 'investigatorFullName': 'Pin-Kuei Fu, MD, PhD', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}