Bronchial Thermoplasty 10+ Year Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies

Conditions
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Asthma

Intervention / Treatment
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* Other: Bronchial Thermoplasty


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated<br>Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2) | Other: Bronchial Thermoplasty<br>* patients had radio frequency ablation of the smooth muscle for asthma<br>|
| Control<br>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<br>* patients had radio frequency ablation of the smooth muscle for asthma<br>|
| Sham<br>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<br>* patients had radio frequency ablation of the smooth muscle for asthma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial Thermoplasty, Alair, Registry