Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214539
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2005-09-15
Brief Title:
Research in Severe Asthma RISA Trial
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Multicenter Randomized Clinical Trial of Bronchial Thermoplasty With the Alair System for the Treatment of Severe Asthma
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma
This will be a multicenter randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy A total of 30 subjects will be randomized 11 to the Alair Group Medical management Alair Treatment OR the 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 in patients with severe asthma refractory to standard medication therapy A total of 30 subjects will be randomized 11 to the Alair Group Medical management Alair Treatment OR the Control Group Medical management only
Detailed Description:
Multicenter randomized clinical trial conducted at 8 Investigational Sites in 3 countries
Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions while subjects in the Control group will complete 3 Control Visits to the Physicians office timed to coincide with the 3 treatment bronchoscopy sessions Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase
Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks termed the Steroid Wean Phase during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids ICS or if taking maintenance oral corticosteroids OCS their oral steroids If a subject cannot tolerate the steroid reduction at a particular level as evidenced by loss of asthma control they will be stabilized on their last tolerable dose of steroid
All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks termed the Reduced Steroid Phase All subjects will be exited from the study following completion of the 52 week evaluations
Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions while subjects in the Control group will complete 3 Control Visits to the Physicians office timed to coincide with the 3 treatment bronchoscopy sessions Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase
Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks termed the Steroid Wean Phase during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids ICS or if taking maintenance oral corticosteroids OCS their oral steroids If a subject cannot tolerate the steroid reduction at a particular level as evidenced by loss of asthma control they will be stabilized on their last tolerable dose of steroid
All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks termed the Reduced Steroid Phase All subjects will be exited from the study following completion of the 52 week evaluations
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