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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.
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.
Compare 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2) |
| |
| Control | 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. |
| |
| Sham | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial Thermoplasty | Other | patients had radio frequency ablation of the smooth muscle for asthma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT. | 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. | The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure. |
| Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events. | 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. | The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe asthma exacerbation rates exacerbations | 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: | One day visit |
| Severe asthma exacerbation rates subject |
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Inclusion Criteria
Exclusion Criteria:
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Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2) will be invited to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bowman, MD | Medical Director, Boston Scientific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Henry Ford Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33524320 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2018 | Jul 9, 2020 | Prot_000.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000074060 | Bronchial Thermoplasty |
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
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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:
| One day visit |
| Severe asthma exacerbation rates year | 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: | One day visit |
| rates of emergency room visits for respiratory adverse events | 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: | One day visit |
| proportion of subjects with emergency room visits for respiratory adverse events | 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: | One day visit |
| Rates of hospitalizations for respiratory adverse events | 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: | One day visit |
| Proportion of subjects with hospitalizations for respiratory adverse events | 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: | One day visit |
| Rates of Respiratory Serious Adverse Events (SAEs) | 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: | One day visit |
| Proportion of subjects with respiratory SAEs) | 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: | One day visit |
| Detroit |
| Michigan |
| 48202-268 |
| United States |
| Regions Hospital Health Partners Specialty Center | Saint Paul | Minnesota | 55130 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110-1093 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Pulmonary Associates of Northern Virginia | Arlington | Virginia | 22205 | United States |
| Imandade Santa Casa de Misercordia | Pôrto Alegre | Rio Grande do Sul | 90035074 | Brazil |
| Faculdade da Medicina do ABC | Santo André | São Paulo | 09060-650 | Brazil |
| Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides | Pôrto Alegre | 90480-000 | Brazil |
| Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ | Rio de Janeiro | 21949-900 | Brazil |
| Montreal Chest Institute | Montreal | Quebec | H4A 3J1 | Canada |
| Institute Universitaire de Cardiologie et Pneumologie de Quebec | Québec | Quebec | G1V4G5 | Canada |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Chelsea and Westminster Hospital | Chelsea | London | SW10 9NH | United Kingdom |
| Gartnavel General Hospital | Glasgow | Scotland | G12 OYN | United Kingdom |
| University of Leicester Glenfield Hospital | Leicester | LE5 4PW | United Kingdom |
| Wythenshawe Hospital, University of Manchester | Manchester | M23 9LT | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |