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RISA Extension Study - Long Term Safety

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Asthmatx, Inc.
ClinicalTrials.gov Identifier:
NCT00401986
First received: November 17, 2006
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Asthma
 Device: Bronchial thermopladsty with the Alair System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Asthmatx, Inc.:

Estimated Enrollment: 15
Study Start Date: December 2006
Groups/Cohorts Assigned Interventions
Alair Treatment
Alair Treated subject6s from PREDECESSOR STUDY
 Device: Bronchial thermopladsty with the Alair System
Treatment of airways with the Alair System in PREDECESSOR STUDY

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401986

Locations
Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90570-080
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
Hospital Laval, University of Laval
Sainte-Foy, Quebec, Canada, G1V 4G5
United Kingdom
Gartnavel General Hospital, Univ. Glasgow
Glasgow, United Kingdom
Glenfield General Hospital, Univ. Leicester
Leicester, United Kingdom, LE3 9QP
National Heart and Lung Institute, Imperial College
London, United Kingdom, SW3 6NP
Northwest Lung Research Center, University of Manchester
Manchester, United Kingdom, M23 9LT
William Leech Center, Freeman Hospital
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Asthmatx, Inc.
Investigators
Study Director: Narinder S Shargill, PhD Asthmatx, Inc.
  More Information

No publications provided

Responsible Party: Asthmatx, Inc.
ClinicalTrials.gov Identifier: NCT00401986     History of Changes
Other Study ID Numbers: 06-01
Study First Received: November 17, 2006
Last Updated: May 25, 2012
Health Authority: Canada: Health Canada
Brazil: National Committee of Ethics in Research
United Kingdom: Research Ethics Committee

Keywords provided by Asthmatx, Inc.:
Refractory Asthma
Bronchial Thermoplasty
Alair System
RISA (Research in Severe Asthma)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013