China Alair System Registry Study-CARE Study

Study Overview
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Brief Summary
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The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.

Detailed Description
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Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.

Official Title
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Registry of Bronchial Thermoplasty (BT) Procedures in China

Conditions
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Asthma

Intervention / Treatment
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* Device: Alair System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU). Exclusion Criteria: Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator). Patient has any other medical condition that would make them inappropriate for study participation, 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<br>This is a single arm study with Alair system used. | Device: Alair System<br>* The Alair system is used for doing bronchial thermoplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe asthma exacerbations following BT with the Alair System. | Severe asthma exacerbation is defined as worsening of asthma symptoms requiring use of systemic corticosteroids (tablets, suspension, or injection) (NAEPP Guidelines, 2007). For patients already taking oral corticosteroids on a daily or alternate day basis, a severe asthma exacerbation is defined as a worsening of asthma symptoms requiring any increase in daily dose of systemic corticosteroids. For consistency, courses of corticosteroids separated by 1 week or more will be treated as separate severe exacerbations. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quarlity of life of Patients | Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ) | 1 year | 
| Health care utilization | Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits | 1 year | 
| FEV1 | Pre- and post-bronchodilator FEV1 | 1 year | 
| Serious respiratory adverse events | Rates of and proportion of patients with serious respiratory adverse events | 1 year |