Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-28 @ 2:28 PM
Study NCT ID:
NCT03243292
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bronchial Thermoplasty 10+ Year Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-30', 'size': 2468670, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-09T15:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.', 'timeFrame': "The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.", 'description': 'Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.'}, {'measure': "Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.", 'timeFrame': "The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.", 'description': 'Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.'}], 'secondaryOutcomes': [{'measure': 'Severe asthma exacerbation rates exacerbations', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'Severe asthma exacerbation rates subject', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'Severe asthma exacerbation rates year', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'rates of emergency room visits for respiratory adverse events', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'proportion of subjects with emergency room visits for respiratory adverse events', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'Rates of hospitalizations for respiratory adverse events', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'Proportion of subjects with hospitalizations for respiratory adverse events', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'Rates of Respiratory Serious Adverse Events (SAEs)', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}, {'measure': 'Proportion of subjects with respiratory SAEs)', 'timeFrame': 'One day visit', 'description': 'evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchial Thermoplasty', 'Alair', 'Registry'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '33524320', 'type': 'DERIVED', 'citation': 'Chaudhuri R, Rubin A, Sumino K, Lapa E Silva JR, Niven R, Siddiqui S, Klooster K, McEvoy C, Shah PL, Simoff M, Khatri S, Barbers R, Mark Grubb G, McMullen EA, Olson JL, Laviolette M; BT10+ Study Group. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials. Lancet Respir Med. 2021 May;9(5):457-466. doi: 10.1016/S2213-2600(20)30408-2. Epub 2021 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.', 'detailedDescription': 'Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.\n\nCompare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2) will be invited to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Subjects previously enrolled in AIR, RISA or AIR2\n* Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment\n* Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks\n* Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements\n\nExclusion Criteria:\n\n* Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.'}, 'identificationModule': {'nctId': 'NCT03243292', 'briefTitle': 'Bronchial Thermoplasty 10+ Year Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies', 'orgStudyIdInfo': {'id': '92115848'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treated', 'description': 'Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)', 'interventionNames': ['Other: Bronchial Thermoplasty']}, {'label': 'Control', 'description': 'Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT.', 'interventionNames': ['Other: Bronchial Thermoplasty']}, {'label': 'Sham', 'description': 'Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT.', 'interventionNames': ['Other: Bronchial Thermoplasty']}], 'interventions': [{'name': 'Bronchial Thermoplasty', 'type': 'OTHER', 'description': 'patients had radio frequency ablation of the smooth muscle for asthma', 'armGroupLabels': ['Control', 'Sham', 'Treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '48202-268', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hospital Health Partners Specialty Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63110-1093', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pulmonary Associates of Northern Virginia', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '90035074', 'city': 'Pôrto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Imandade Santa Casa de Misercordia'}, {'zip': '09060-650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade da Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '90480-000', 'city': 'Pôrto Alegre', 'country': 'Brazil', 'facility': 'Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides', 'geoPoint': {'lat': -9.75, 'lon': -46.16667}}, {'zip': '21949-900', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Chest Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institute Universitaire de Cardiologie et Pneumologie de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'SW10 9NH', 'city': 'Chelsea', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.48755, 'lon': -0.16936}}, {'zip': 'G12 OYN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Gartnavel General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University of Leicester Glenfield Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital, University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Thomas Bowman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director, Boston Scientific'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}