Asthma
Conditions
Keywords
Bronchial Thermoplasty, Alair, Registry
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.
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.
Interventions
patients had radio frequency ablation of the smooth muscle for asthma
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: |
Countries
Brazil, Canada, Netherlands, United Kingdom, United States
Outcome results
None listed