RISA Extension Study - Long Term Safety
Recruitment status was Active, not recruiting
|First Received Date ICMJE||November 17, 2006|
|Last Updated Date||May 25, 2012|
|Start Date ICMJE||December 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00401986 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||RISA Extension Study - Long Term Safety|
|Official Title ICMJE||Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY
|Intervention ICMJE||Device: Bronchial thermopladsty with the Alair System
Treatment of airways with the Alair System in PREDECESSOR STUDY
|Study Group/Cohort (s)||Alair Treatment
Alair Treated subject6s from PREDECESSOR STUDY
Intervention: Device: Bronchial thermopladsty with the Alair System
|Publications *||Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||15|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Brazil, Canada, United Kingdom|
|NCT Number ICMJE||NCT00401986|
|Other Study ID Numbers ICMJE||06-01|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Asthmatx, Inc.|
|Study Sponsor ICMJE||Asthmatx, Inc.|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Asthmatx, Inc.|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP