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Sponsored by: |
Asthmatx, Inc. |
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Information provided by: | Asthmatx, Inc. |
ClinicalTrials.gov Identifier: | NCT00448812 |
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) 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. 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, including spirometry, physical examinations, review of symptoms, use of maintenance and rescue medications, and response to Methacholine challenge.
Condition | Intervention |
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Asthma |
Device: Bronchial Thermoplasty with the Alair System |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Extension Study for the Multicenter Randomized Clinical Trial of the Alair® System for the Bronchial Thermoplasty Treatment of Asthma |
Estimated Enrollment: | 109 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Alair Treatment
Alair treated subjects from PREDECESSOR STUDY
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Device: Bronchial Thermoplasty with the Alair System
Treatment of airways with the Alair System in the PREDECESSOR STUDY
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2: No Intervention
Control group subjects from PREDECESSOR STUDY
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Device: Bronchial Thermoplasty with the Alair System
Treatment of airways with the Alair System in the PREDECESSOR STUDY
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This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY.
Written, informed consent will be obtained prior to performing any study procedures. Enrollment will be limited to only those subjects who were in either the Control or Treatment groups of the PREDECESSOR STUDY.
The present study will extend the follow-up evaluation of subjects from the PREDECESSOR STUDY to 3 years post-treatment for the Control Subjects and 5 years post-treatment for Alair-Treated Subjects. These evaluations will consist of two (Control Group) to four (Alair Group) additional study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of Alair treatments (or similar time point for control subjects) in the PREDECESSOR STUDY. For consistency with the PREDECESSOR STUDY, ideally the subject's drug therapy should continue to be consistent with GINA Guidelines for the severity of the subject's asthma. Any changes in maintenance levels of asthma medications should be documented.
The goal of this follow-on study is to enroll all subjects who participated in the PREDECESSOR STUDY. Inclusion of subjects from the treatment arm will allow for the assessment of long-term safety of the Alair procedure for up to 5 years post treatment with the Alair System. Inclusion of subjects from the Control arm will allow for appropriate analysis of long-term effectiveness data for up to 3 years post "treatment".
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, RS | |
Irmandade Santa Casa de Misericordia de Porto Alegre | |
Porto Alegre, RS, Brazil, CEP 90035 074 | |
Canada, Ontario | |
St. Joseph's Healthcare | |
Hamilton, Ontario, Canada, L8N 4A6 | |
Canada, Quebec | |
Hopital Laval, Laval University | |
Sainte-Foy, Quebec, Canada, G1V 4GS | |
United Kingdom | |
Northwest Lung Research Center, Univ. Manchester | |
Manchester, United Kingdom, M23 9LT | |
United Kingdom, Scotland | |
Gartnavel General Hospital, Univ. Glasgow | |
Glasgow, Scotland, United Kingdom, G12 0YN |
Study Director: | Narinder S Shargill, PhD | Asthmatx, Inc. |
Responsible Party: | Asthmatx, Inc. ( Narinder Singh Shargill, PhD. ) |
Study ID Numbers: | 05-01 |
Study First Received: | March 16, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00448812 |
Health Authority: | Canada: Health Canada; United Kingdom: Research Ethics Committee; Brazil: National Committee of Ethics in Research; Denmark: Ethics Committee |
Alair System Bronchial Thermoplasty Long-term Safety |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |