At a glance
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Extension Study for the Multicenter Randomized Clinical Trial of the Alair® System for the Bronchial Thermoplasty Treatment of Asthma (NCT00214526)
In Brief
A clinical study evaluating Bronchial Thermoplasty with the Alair System for Asthma. Completed, enrolled 69 participants across 5 sites in 3 countries.
Detailed Summary
The primary purpose of this study is to gather additional safety data for subjects who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma" (Protocol #0602-20, NCT00214526) sponsored by Asthmatx, Inc. Study Subjects who were assigned to the Control Group who elect to participate in this extension study will be followed for an additional two (2) - year period beyond the PREDECESSOR STUDY'S one-year endpoint. Subjects treated with the Alair System who elect to participate in this extension study will be followed for an additional four (4)- year period beyond the PREDECESSOR STUDY'S one-year endpoint. All treatments with the Alair System were completed in the PREDECESSOR STUDY (NCT00214526). The current study is designed solely to collect longer-term follow-up data on the effects of the treatments. The data will be of the same type that was collected in the PREDECESSOR STUDY (NCT00214526), including spirometry, physical examinations, review of symptoms, use of maintenance and rescue medications, and response to Methacholine challenge.
Study Details
Timeline
Interventions
Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526).