AIR Extension Study - Long-Term Safety of Alair Treated Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The primary purpose of this study is to gather additional safety data for subjects who
      previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of
      the Alair System for the Bronchial Thermoplasty Treatment of Asthma" (Protocol #0602-20,
      NCT00214526) sponsored by Asthmatx, Inc. Study Subjects who were assigned to the Control
      Group who elect to participate in this extension study will be followed for an additional two
      (2) - year period beyond the PREDECESSOR STUDY'S one-year endpoint. Subjects treated with the
      Alair System who elect to participate in this extension study will be followed for an
      additional four (4)- year period beyond the PREDECESSOR STUDY'S one-year endpoint.

      All treatments with the Alair System were completed in the PREDECESSOR STUDY (NCT00214526).
      The current study is designed solely to collect longer-term follow-up data on the effects of
      the treatments. The data will be of the same type that was collected in the PREDECESSOR STUDY
      (NCT00214526), including spirometry, physical examinations, review of symptoms, use of
      maintenance and rescue medications, and response to Methacholine challenge.
    

Detailed description: 
      This will be a multicenter study conducted only at the clinical sites that participated in
      the PREDECESSOR STUDY (NCT00214526).

      Written, informed consent will be obtained prior to performing any study procedures.
      Enrollment will be limited to only those subjects who were in either the Control or Treatment
      groups of the PREDECESSOR STUDY (NCT00214526).

      The present study will extend the follow-up evaluation of subjects from the PREDECESSOR STUDY
      (NCT00214526) to 3 years post-treatment for the Control Subjects and 5 years post-treatment
      for Alair-Treated Subjects. These evaluations will consist of two (Control Group) to four
      (Alair Group) additional study visits corresponding to the two-year, three-year, four-year
      and five-year time points following completion of Alair treatments (or similar time point for
      control subjects) in the PREDECESSOR STUDY (NCT00214526). For consistency with the
      PREDECESSOR STUDY (NCT00214526), ideally the subject's drug therapy should continue to be
      consistent with the Global Initiative for Asthma (GINA) Guidelines for the severity of the
      subject's asthma. Any changes in maintenance levels of asthma medications should be
      documented.

      The goal of this follow-up study is to enroll all subjects who participated in the
      PREDECESSOR STUDY (NCT00214526). Inclusion of subjects from the treatment arm will allow for
      the assessment of long-term safety of the Alair procedure for up to 5 years post treatment
      with the Alair System. Inclusion of subjects from the Control arm will allow for appropriate
      analysis of long-term effectiveness data for up to 3 years post "treatment".
    

Intervention name(s): Bronchial Thermoplasty with the Alair System
Intervention type(s): Device
Intervention description(s): Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alair System; Bronchial Thermoplasty; Long-term Safety