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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080032 / PAS002 |
| Date Original Protocol Accepted |
04/27/2010
|
| Date Current Protocol Accepted |
09/14/2010
|
| Study Name |
New Patient Study
|
| Device Name |
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, open-label, multi-center, single-arm study conducted in the United States and Canada
|
| Study Population |
Adults (18-65 years) with asthms
|
| Sample Size |
Enroll up to 300 adult subjects (a minimum of 250 subjects)
|
| Key Study Endpoints |
The primary endpoint is the proportion of subjects experiencing severe exacerbations during the subsequent 12-month periods (for Years 2, 3, 4, and 5) compared to the first 12-month proportion after the Alair treatment.
|
| Follow-up Visits and Length of Follow-up |
Up to 5 years from the end of last treatment.
Every 6 months between annul visits, and annul visits at 1, 2, 3, 4, and 5 years from the end of last treatment.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
279
|
| Actual Number of Sites Enrolled |
27
|
| Patient Follow-up Rate |
271 – Subjects Enrolled and received at least one treatment (97%)
262 – Subjects completed 1 year follow up (94%)
249 – Subjects completed 2 year follow up (89%)
244 – Subjects completed 3 year follow up (88%)
237 – Subjects completed 4 year follow up (85%)
227 – Subjects completed 5 year follow up (81%)
|
| 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 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.
|
| 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 50.4%, 46.6%, 47.1%, 44.7%, and 42.7%, 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 was open-label, single arm, which may introduce the placebo effect. The subject population is predominately Caucasians (~80%), thus, the results may best represent the Caucasian population.
|
| Recommendations for Labeling Changes |
Update the label with the respiratory-related serious adverse event rates.
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