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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-AIR2 - Extended Study

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Study Status Completed
Application Number P080032 / PAS001
Date Current Protocol Accepted 07/27/2010
Study Name OSB Lead-AIR2 - Extended Study
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

OSB Lead-AIR2 - Extended Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/26/2010 10/25/2010 On Time
1 year report 04/27/2011 04/28/2011 Overdue/Received
18 month report 10/26/2011 10/25/2011 On Time
2 year report 04/26/2012 04/26/2012 On Time
3 year report-FINAL 04/26/2013 04/26/2013 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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