Status:
COMPLETED
AIR Extension Study - Long-Term Safety of Alair Treated Subjects
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214526). Written, informed consent will be obtained prior to performing any stud...
Eligibility Criteria
Inclusion
- Subject who participated in the PREDECESSOR STUDY entitled "Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma"(Protocol # 0602-20, NCT00214526).
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00448812
Start Date
March 1 2005
End Date
April 1 2010
Last Update
February 17 2021
Active Locations (5)
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1
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, CEP 90035 074
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
3
Hopital Laval, Laval University
Sainte-Foy, Quebec, Canada, G1V 4GS
4
Gartnavel General Hospital, Univ. Glasgow
Glasgow, Scotland, United Kingdom, G12 0YN