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Sponsored by: |
Asthmatx, Inc. |
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Information provided by: | Asthmatx, Inc. |
ClinicalTrials.gov Identifier: | NCT00214526 |
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).
Condition | Intervention |
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Asthma |
Procedure: Bronchial Thermoplasty with the Alair System |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Randomized Clinical Trial of the AlairTM System for the Bronchial Thermoplasty Treatment of Asthma |
Estimated Enrollment: | 110 |
Study Start Date: | November 2002 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Protocol #0602-20 |
Study First Received: | September 15, 2005 |
Last Updated: | December 7, 2005 |
ClinicalTrials.gov Identifier: | NCT00214526 |
Health Authority: | Canada: Health Canada |
Asthma Bronchial Thermoplasty Airway Hyperresponsiveness |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |