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Clinical Trial Summary

As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.


Clinical Trial Description

This is a multicenter, open-label, single arm study designed to demonstrate durability of the treatment effect and to evaluate the short-term and longer-term safety profile of the Alair System in the United States in the intended use population (patients 18 years and older with severe persistent asthma). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01350336
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date April 7, 2011
Completion date March 17, 2020

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