|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080032 / PAS001 |
| Date Original Protocol Accepted |
07/27/2010
|
| Date Current Protocol Accepted |
07/27/2010
|
| Study Name |
AIR2 - Extended Study
|
| Device Name |
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
190
|
| Actual Number of Sites Enrolled |
30
|
| Patient Follow-up Rate |
Follow-up rates were 95.2%, 87.4%, 85.3%, 83.7%, and 85.3% at years 1-5, respectively.
|
| Final Safety Findings |
There were six safety endpoints evaluated after the Alair treatment, and they were acceptable at 5 years follow-up. The Rates for Severe Exacerbation Event, for Respiratory Adverse Event (events/subject/year), for Emergency Room Visits for respiratory symptoms (events/subject/year), and for Hospitalizations for respiratory symptoms (events/subject/year) in each subsequent year (2 through 5) compared to year 1 post therapy (0.486, 2.0, 0.07, 0.039) were non- inferior and were sustained through year five. There was no increase in the above rates and Respiratory Serious Adverse Events over time. FEV1 did not deteriorate over 5 years. There were no structural changes in the airways based on the review of 93 High-resolution computed tomography (HRCT) pairs at Baseline and at Year 5.
|
| Final Effect Findings |
The proportions of subjects (expressed in percentages) experiencing one or more severe exacerbations in Years 1-5 after the Alair treatment were 30.9%, 23.6%, 34.0%, 36.5%, and 21.6%, respectively. The upper 95% confidence limit of the difference between the subsequent 12-month proportions (for Years 2, 3, 4, and 5) compared to the first 12-month proportion remained less than the pre-specified non-inferiority margin of 20%. Therefore, the proportions are not significantly worse, i.e. the primary endpoint for the study has been met. Treatment effectiveness is durable out to five years.
|
| Study Strengths & Weaknesses |
The study cohort was originally randomized and treated. However, during the 5-year follow-up, it became an open-label single-arm study, i.e. subjects became unblinded to treatment introducing a possible placebo effect. The subject population is predominately Caucasians (~80%), thus, the results may best represent the Caucasian population.
|
| Recommendations for Labeling Changes |
None
|
