RISA Extension Study - Long Term Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401986
Recruitment Status : Unknown
Verified May 2012 by Asthmatx, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2006
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):
Asthmatx, Inc.

November 17, 2006
November 22, 2006
May 30, 2012
December 2006
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Complete list of historical versions of study NCT00401986 on Archive Site
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RISA Extension Study - Long Term Safety
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.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY
Device: Bronchial thermopladsty with the Alair System
Treatment of airways with the Alair System in PREDECESSOR STUDY
Alair Treatment
Alair Treated subject6s from PREDECESSOR STUDY
Intervention: Device: Bronchial thermopladsty with the Alair System
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 Identifier (NCT Number) in Medline.
Unknown status
Same as current
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   United Kingdom
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Asthmatx, Inc.
Asthmatx, Inc.
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Study Director: Narinder S Shargill, PhD Asthmatx, Inc.
Asthmatx, Inc.
May 2012