Asthma Clinical Trial
Official title:
Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System
for the treatment of asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment
with the Alair System to standard drug therapy. One-hundred and ten subjects will be
randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control
Group (Medical management only).
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in
4 countries (Canada, United Kingdom, Denmark, and Brazil).
Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up
evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit.
In order to maximize the power of the study, Baseline and Follow-up testing was conducted in
2 parts. In the first part subjects continued to take their asthma maintenance medications
(inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period.
This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to
abstain from LABA for the second part of the testing, and these results are designated as
the "OFF-LABA" Phase.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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