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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alair System | This is a single arm study with Alair system used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alair System | Device | The Alair system is used for doing bronchial thermoplasty. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The real world patient polulaiton who undergo BT in China
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| Name | Affiliation | Role |
|---|---|---|
| Jiangtao Lin, Professor | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BSC International Medical Trading (Shanghai) Co., Ltd. | Shanghai | Shanghai Municipality | 200023 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |