Conditions: Asthma
Keywords: Asthma Bronchial Thermoplasty Airway Hyperresponsiveness
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 112
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. arm 2: Conventional therapy with ICS+LABA.

Interventions: intervention 1: Bronchial thermoplasty with the Alair System intervention 2: Conventional therapy with ICS+LABA
Intervention descriptions: intervention 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. intervention 2: Conventional therapy with ICS+LABA.

Protocol document: