Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02464995
Status:
UNKNOWN
Last Update Posted:
2019-05-30
First Post:
2015-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074060', 'term': 'Bronchial Thermoplasty'}], 'ancestors': [{'id': 'D017115', 'term': 'Catheter Ablation'}, {'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-11-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe exacerbation rate (change from baseline)', 'timeFrame': 'Baseline, 6 months and 12 months after the last thermoplasty procedure', 'description': 'A severe exacerbation is defined by a burst of systemic corticosteroids \\>3 days'}], 'secondaryOutcomes': [{'measure': 'Time to the first severe asthma exacerbation', 'timeFrame': 'anytime'}, {'measure': 'Mean oral glucocorticosteroid dose (mg equivalent prednisone)', 'timeFrame': 'Baseline, 6 and 12 Months'}, {'measure': 'Mild exacerbation rate', 'timeFrame': 'Baseline, 6 and 12 Months'}, {'measure': 'Pre- and post-bronchodilator FEV1', 'timeFrame': 'Baseline, 6 and 12 Months'}, {'measure': 'Asthma Control Questionnaire (ACQ) Score', 'timeFrame': 'Baseline, 3, 6, 9 and 12 Months'}, {'measure': 'Asthma Quality of Life Questionnaire (AQLQ) Score', 'timeFrame': 'Baseline, 3, 6, 9 and 12 Months'}, {'measure': 'Structural airway remodeling using CT', 'timeFrame': 'Baseline and 12 Months'}, {'measure': 'Inflammatory cells and markers in induced sputum', 'timeFrame': 'Time Frame: Baseline and 12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma,', 'Asthma exacerbation', 'Bronchial thermoplasty'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.\n\nThis will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids \\>3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 18-65 years\n* Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5\n* Four or more bursts of systemic corticosteroids \\>3 days each in the previous year\n* Willingness and ability to give written informed consent\n\nExclusion criteria:\n\n* Current smoker and former smoker \\> 10 pack years total smoking history\n* Participation in another clinical trial within the prior 4 months\n* Omalizumab therapy within the prior 4 months\n* Allergic bronchopulmonary aspergillosis\n* Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (\\> 60 mg equivalent prednisolone) more than one month in the previous year\n* Post-bronchodilator FEV1 of less than 30%\n* Past diagnosis of COPD and chronic respiratory insufficiency\n* Known coagulopathy or platelet dysfunction\n* Use of anticoagulants\n* Use of an internal or external pacemaker or internal cardiac defibrillator\n* Contraindication to perform bronchoscopy\n* Contraindication to perform general anesthesia\n* Significant cardiovascular disease\n* Current or recent respiratory tract infection resolved less than 4 weeks\n* Known cancer or cancer history less than 12 months\n* Pregnancy and nursing mother'}, 'identificationModule': {'nctId': 'NCT02464995', 'acronym': 'THERMASCORT', 'briefTitle': 'Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations', 'orgStudyIdInfo': {'id': '5886'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermoplasty group', 'description': 'Procedure: Bronchial thermoplasty with the Alair System and conventional therapy', 'interventionNames': ['Device: Bronchial thermoplasty with the Alair System']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Conventional therapy'}], 'interventions': [{'name': 'Bronchial thermoplasty with the Alair System', 'type': 'DEVICE', 'armGroupLabels': ['Thermoplasty group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Naji KHAYATH, PhD', 'role': 'CONTACT', 'email': 'naji.khayath@chru-strasbourg.fr'}], 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}