Bronchial Thermoplasty 10+ Year Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treated Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2) |
Other: Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
|
| 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. |
Other: Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
|
| 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. |
Other: Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
|
Outcome Measures
Primary Outcome Measures
- Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT. [The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.]
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.
- Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events. [The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.]
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.
Secondary Outcome Measures
- Severe asthma exacerbation rates exacerbations [One day visit]
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:
- Severe asthma exacerbation rates subject [One day visit]
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:
- Severe asthma exacerbation rates year [One day visit]
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:
- rates of emergency room visits for respiratory adverse events [One day visit]
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:
- proportion of subjects with emergency room visits for respiratory adverse events [One day visit]
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:
- Rates of hospitalizations for respiratory adverse events [One day visit]
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:
- Proportion of subjects with hospitalizations for respiratory adverse events [One day visit]
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:
- Rates of Respiratory Serious Adverse Events (SAEs) [One day visit]
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:
- Proportion of subjects with respiratory SAEs) [One day visit]
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:
Eligibility Criteria
Criteria
Inclusion Criteria
-
Subjects previously enrolled in AIR, RISA or AIR2
-
Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
-
Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
-
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
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90033 |
| 2 | Henry Ford Health System | Detroit | Michigan | United States | 48202-268 |
| 3 | Regions Hospital Health Partners Specialty Center | Saint Paul | Minnesota | United States | 55130 |
| 4 | Washington University Medical Center | Saint Louis | Missouri | United States | 63110-1093 |
| 5 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 6 | Pulmonary Associates of Northern Virginia | Arlington | Virginia | United States | 22205 |
| 7 | Imandade Santa Casa de Misercordia | Pôrto Alegre | RS | Brazil | 90035074 |
| 8 | Faculdade da Medicina do ABC | Santo André | Sao Paulo | Brazil | 09060-650 |
| 9 | Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides | Pôrto Alegre | Brazil | 90480-000 | |
| 10 | Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ | Rio De Janeiro | Brazil | 21949-900 | |
| 11 | Montreal Chest Institute | Montréal | Quebec | Canada | H4A 3J1 |
| 12 | Institute Universitaire de Cardiologie et Pneumologie de Quebec | Quebec City | Quebec | Canada | G1V4G5 |
| 13 | Universitair Medisch Centrum Groningen | Groningen | Netherlands | 9713 GZ | |
| 14 | Chelsea and Westminster Hospital | Chelsea | London | United Kingdom | SW10 9NH |
| 15 | Gartnavel General Hospital | Glasgow | Scotland | United Kingdom | G12 OYN |
| 16 | University of Leicester Glenfield Hospital | Leicester | United Kingdom | LE5 4PW | |
| 17 | Wythenshawe Hospital, University of Manchester | Manchester | United Kingdom | M23 9LT |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Thomas Bowman, MD, Medical Director, Boston Scientific
Study Documents (Full-Text)
More Information
Publications
None provided.- 92115848