Bronchial Thermoplasty Global Registry

Study Overview
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Brief Summary
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The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.

Detailed Description
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This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the real world setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications. The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up. The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.

Official Title
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Bronchial Thermoplasty (BT) Global Registry

Conditions
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Asthma

Intervention / Treatment
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* Device: Alair System (Bronchial Thermoplasty)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements. Exclusion Criteria: 1. Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Alair System (Bronchial Thermoplasty)<br>Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use. | Device: Alair System (Bronchial Thermoplasty)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who experience severe asthma exacerbations | The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Quality of Life Questionnaire (AQLQ) score | Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT. | 2 years | 
| Asthma Control Test (ACT) score | Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT. | 2 years | 
| Emergency department visits for asthma symptoms | Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT. | 2 years | 
| Hospitalizations for asthma symptoms | Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT. | 2 years | 
| Unscheduled office visits including urgent care visits for asthma symptoms. | Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT. | 2 years | 
| Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1) | Pre- and post-bronchodilator FEV1 will be summarized for Year 1 and Year 2 post-BT treatment (% predicted and absolute value). Change from baseline will also be summarized. | 2 years | 
| Respiratory Adverse Events | Separated by treatment period and post-treatment period | 2 years | 
| Lung Volumes | Collected at sites where it is standard of care | 2 years | 
| Diffusion Capacity | Collected at sites where it is standard of care | 2 years | 
| Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.) | Collect asthma maintenance medications at all sites | 2 years | 
| Patient satisfaction survey score | Two question survey collected at 12 month and 24 month annual visit | 2 years | 
| Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold) | Collected at sites where it is standard of care | 2 years | 
| Sputum eosinophils | Collected at sites where it is standard of care | 2 years | 
| Exhaled nitric oxide (eNO) | Collected at sites where it is standard of care | 2 years | 
| Methacholine challenge (Methacholine PC20) | Collected at sites where it is standard of care | 2 years | 

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