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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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New Patient Study


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General
Study Status Progress Adequate
Application Number P080032 / PAS002
Date Current Protocol Accepted 09/14/2010
Study Name New Patient Study
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 Design Description Prospective, open-label, multi-center, single-arm study conducted in the United States and Canada
Study Population Description Adults (18-65 years) with asthms
Sample Size Enroll up to 300 adult subjects (a minimum of 250 subjects)
Data Collection 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.


New Patient Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/26/2010 10/25/2010 On Time
case report forms 02/11/2011 02/11/2011 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 04/26/2013 04/26/2013 On Time
4 year report 04/26/2014 04/25/2014 On Time
5 year report 04/26/2015 04/24/2015 On Time
6 year report 04/26/2016 04/25/2016 On Time
7 year report 04/26/2017 04/26/2017 On Time
8 year report 04/26/2018 04/27/2018 Overdue/Received
9 year report 04/26/2019 05/03/2019 Overdue/Received
10 year report 04/26/2020 04/24/2020 On Time
final report 04/26/2021 04/23/2021 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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