Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448812
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2007-03-16
Brief Title:
AIR Extension Study - Long-Term Safety of Alair Treated Subjects
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Extension Study for the Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma NCT00214526
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIRx
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 the Bronchial Thermoplasty Treatment of Asthma Protocol 0602-20 NCT00214526 sponsored by Asthmatx Inc Study Subjects who were assigned to the Control Group who elect to participate in this extension study will be followed for an additional two 2 - year period beyond the PREDECESSOR STUDYS one-year endpoint Subjects treated with the Alair System who elect to participate in this extension study will be followed for an additional four 4- year period beyond the PREDECESSOR STUDYS one-year endpoint
All treatments with the Alair System were completed in the PREDECESSOR STUDY NCT00214526 The current study is designed solely to collect longer-term follow-up data on the effects of the treatments The data will be of the same type that was collected in the PREDECESSOR STUDY NCT00214526 including spirometry physical examinations review of symptoms use of maintenance and rescue medications and response to Methacholine challenge
All treatments with the Alair System were completed in the PREDECESSOR STUDY NCT00214526 The current study is designed solely to collect longer-term follow-up data on the effects of the treatments The data will be of the same type that was collected in the PREDECESSOR STUDY NCT00214526 including spirometry physical examinations review of symptoms use of maintenance and rescue medications and response to Methacholine challenge
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 study procedures Enrollment will be limited to only those subjects who were in either the Control or Treatment groups of the PREDECESSOR STUDY NCT00214526
The present study will extend the follow-up evaluation of subjects from the PREDECESSOR STUDY NCT00214526 to 3 years post-treatment for the Control Subjects and 5 years post-treatment for Alair-Treated Subjects These evaluations will consist of two Control Group to four Alair Group additional study visits corresponding to the two-year three-year four-year and five-year time points following completion of Alair treatments or similar time point for control subjects in the PREDECESSOR STUDY NCT00214526 For consistency with the PREDECESSOR STUDY NCT00214526 ideally the subjects drug therapy should continue to be consistent with the Global Initiative for Asthma GINA Guidelines for the severity of the subjects asthma Any changes in maintenance levels of asthma medications should be documented
The goal of this follow-up study is to enroll all subjects who participated in the PREDECESSOR STUDY NCT00214526 Inclusion of subjects from the treatment arm will allow for the assessment of long-term safety of the Alair procedure for up to 5 years post treatment with the Alair System Inclusion of subjects from the Control arm will allow for appropriate analysis of long-term effectiveness data for up to 3 years post treatment
Written informed consent will be obtained prior to performing any study procedures Enrollment will be limited to only those subjects who were in either the Control or Treatment groups of the PREDECESSOR STUDY NCT00214526
The present study will extend the follow-up evaluation of subjects from the PREDECESSOR STUDY NCT00214526 to 3 years post-treatment for the Control Subjects and 5 years post-treatment for Alair-Treated Subjects These evaluations will consist of two Control Group to four Alair Group additional study visits corresponding to the two-year three-year four-year and five-year time points following completion of Alair treatments or similar time point for control subjects in the PREDECESSOR STUDY NCT00214526 For consistency with the PREDECESSOR STUDY NCT00214526 ideally the subjects drug therapy should continue to be consistent with the Global Initiative for Asthma GINA Guidelines for the severity of the subjects asthma Any changes in maintenance levels of asthma medications should be documented
The goal of this follow-up study is to enroll all subjects who participated in the PREDECESSOR STUDY NCT00214526 Inclusion of subjects from the treatment arm will allow for the assessment of long-term safety of the Alair procedure for up to 5 years post treatment with the Alair System Inclusion of subjects from the Control arm will allow for appropriate analysis of long-term effectiveness data for up to 3 years post treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None