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.
Study Type
OBSERVATIONAL
Enrollment
192
patients had radio frequency ablation of the smooth muscle for asthma
University of Southern California
Los Angeles, California, United States
Henry Ford Health System
Detroit, Michigan, United States
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.
Time frame: 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.
Time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
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:
Time frame: One day visit
Severe asthma exacerbation rates subject
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:
Time frame: 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:
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Regions Hospital Health Partners Specialty Center
Saint Paul, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Pulmonary Associates of Northern Virginia
Arlington, Virginia, United States
Imandade Santa Casa de Misercordia
Pôrto Alegre, Rio Grande do Sul, Brazil
Faculdade da Medicina do ABC
Santo André, São Paulo, Brazil
Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides
Pôrto Alegre, Brazil
Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ
Rio de Janeiro, Brazil
...and 7 more locations
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: One day visit