RISA Extension Study - Long Term Safety
This trial is active, not recruiting.
|Treatment||bronchial thermopladsty with the alair system|
|Start date||December 2006|
|Trial size||15 participants|
|Trial identifier||NCT00401986, 06-01|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Porto Alegre, Brazil||Irmandade Santa Casa de Misericordia de Porto Alegre||no longer recruiting|
|Hamilton, Canada||St. Joseph's Healthcare||no longer recruiting|
|Sainte-Foy, Canada||Hospital Laval, University of Laval||no longer recruiting|
|Glasgow, United Kingdom||Gartnavel General Hospital, Univ. Glasgow||no longer recruiting|
|Leicester, United Kingdom||Glenfield General Hospital, Univ. Leicester||no longer recruiting|
|London, United Kingdom||National Heart and Lung Institute, Imperial College||no longer recruiting|
|Manchester, United Kingdom||Northwest Lung Research Center, University of Manchester||no longer recruiting|
|Newcastle-upon-Tyne, United Kingdom||William Leech Center, Freeman Hospital||no longer recruiting|
Alair Treated subject6s from PREDECESSOR STUDY
Male or female participants at least 18 years old.
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.
|Official title||Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma|
|Description||This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY. 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 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.|
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