RISA Extension Study - Long Term Safety

Study Overview
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Brief Summary
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The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, Alair-Treated Subjects) who previously completed the one-year study entitled: Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).

Detailed Description
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This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214539). Enrollment will be limited to only those subjects who were treated with the Alair System in the PREDECESSOR STUDY. Written, informed consent will be obtained from all subjects prior to performing any study procedures. The present study will extend the follow-up evaluation of Alair-Treated Subjects from the PREDECESSOR STUDY to 5 years post-treatment with the Alair System. These evaluations will consist of four study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of Alair treatments in the PREDECESSOR STUDY. For consistency with the PREDECESSOR STUDY, ideally the subject's drug therapy should continue to be consistent with GINA (Global Initiative for Asthma) Guidelines for the severity of the subject's asthma. Any changes in maintenance levels of asthma medications will be documented. The goal of this follow-on study is to enroll all Alair-Treated Subjects who completed the PREDECESSOR STUDY. Inclusion of subjects from the treatment arm will allow for better assessment of the long-term safety of the Alair procedure.

Official Title
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Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: Bronchial thermoplasty with the Alair System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who participated in the PREDECESSOR STUDY entitled Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair™ System for the Treatment of Severe Asthma (Protocol # 0903-27). Subject was treated with the Alair System (Alair Group) in the PREDECESSOR STUDY. Subject who is able to read, understand, and provide written Informed Consent. Subject who is able to comply with the study protocol, including requirements for taking and abstaining from medications, and complete all study required visits. Exclusion Criteria: Subject participating in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of study enrollment, or during the study period. Subject with a newly diagnosed (since exiting from the PREDECESSOR STUDY) psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.

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 Treatment<br>Alair Treated subjects from PREDECESSOR STUDY (NCT00214539). | Device: Bronchial thermoplasty with the Alair System<br>* Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence. | 2-year, 3-year, 4-year and 5-year follow up post procedure | 
| Respiratory Adverse Events | Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year). | 2-year, 3-year, 4-year and 5-year follow up post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations for Respiratory Symptoms | Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year) | 2-year, 3-year, 4-year and 5-year follow up post procedure | 
| Emergency Room Visits for Respiratory Symptoms | Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year) | 2-year, 3-year, 4-year and 5-year follow up post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Asthma, Bronchial Thermoplasty, Alair System, RISA (Research in Severe Asthma)