Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214526
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2005-09-15
Brief Title:
Asthma Intervention Research AIR Trial
Sponsor:
Asthmatx Inc
Organization:
Asthmatx Inc
Study Overview
Official Title:
Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma
Status:
COMPLETED
Status Verified Date:
2015-08
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:
None
Brief Summary:
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma
This will be a multicenter randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy One-hundred and ten subjects will be randomized 11 to either the Alair Group Medical management Alair treatmentor Control Group Medical management only
This will be a multicenter randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy One-hundred and ten subjects will be randomized 11 to either the Alair Group Medical management Alair treatmentor Control Group Medical management only
Detailed Description:
Multicenter randomized controlled clinical trial conducted at 11 Investigational Sites in 4 countries Canada United Kingdom Denmark and Brazil
Subjects underwent Baseline evaluations Alair treatments or Control Visits and follow-up evaluations at 12-Weeks 6-Months and 12-Months after the last Treatment or Control Visit In order to maximize the power of the study Baseline and Follow-up testing was conducted in 2 parts In the first part subjects continued to take their asthma maintenance medications inhaled corticosteroids ICS and long acting β2-agonists LABA during the test period This is designated as the ON-LABA Phase Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing and these results are designated as the OFF-LABA Phase
Subjects underwent Baseline evaluations Alair treatments or Control Visits and follow-up evaluations at 12-Weeks 6-Months and 12-Months after the last Treatment or Control Visit In order to maximize the power of the study Baseline and Follow-up testing was conducted in 2 parts In the first part subjects continued to take their asthma maintenance medications inhaled corticosteroids ICS and long acting β2-agonists LABA during the test period This is designated as the ON-LABA Phase Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing and these results are designated as the OFF-LABA Phase
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