Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-21 @ 6:23 AM
Study NCT ID:
NCT02206269
Status:
UNKNOWN
Last Update Posted:
2018-02-23
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Alair System Registry Study-CARE Study
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of severe asthma exacerbations following BT with the Alair System.', 'timeFrame': '1 year', 'description': 'Severe asthma exacerbation is defined as worsening of asthma symptoms requiring use of systemic corticosteroids (tablets, suspension, or injection) (NAEPP Guidelines, 2007).\n\nFor patients already taking oral corticosteroids on a daily or alternate day basis, a severe asthma exacerbation is defined as a worsening of asthma symptoms requiring any increase in daily dose of systemic corticosteroids.\n\nFor consistency, courses of corticosteroids separated by 1 week or more will be treated as separate severe exacerbations.'}], 'secondaryOutcomes': [{'measure': 'Quarlity of life of Patients', 'timeFrame': '1 year', 'description': 'Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ)'}, {'measure': 'Health care utilization', 'timeFrame': '1 year', 'description': 'Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits'}, {'measure': 'FEV1', 'timeFrame': '1 year', 'description': 'Pre- and post-bronchodilator FEV1'}, {'measure': 'Serious respiratory adverse events', 'timeFrame': '1 year', 'description': 'Rates of and proportion of patients with serious respiratory adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.', 'detailedDescription': 'Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The real world patient polulaiton who undergo BT in China', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.\n2. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.\n3. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).\n\nExclusion Criteria:\n\n1. Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).\n2. Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion."}, 'identificationModule': {'nctId': 'NCT02206269', 'acronym': 'CARE', 'briefTitle': 'China Alair System Registry Study-CARE Study', 'organization': {'class': 'OTHER', 'fullName': 'BSC International Medical Trading (Shanghai) Co., Ltd.'}, 'officialTitle': 'Registry of Bronchial Thermoplasty (BT) Procedures in China', 'orgStudyIdInfo': {'id': 'E7100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alair System', 'description': 'This is a single arm study with Alair system used.', 'interventionNames': ['Device: Alair System']}], 'interventions': [{'name': 'Alair System', 'type': 'DEVICE', 'description': 'The Alair system is used for doing bronchial thermoplasty.', 'armGroupLabels': ['Alair System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200023', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'BSC International Medical Trading (Shanghai) Co., Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jiangtao Lin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BSC International Medical Trading (Shanghai) Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}