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Asthmatx Pivotal Trial Manuscript for Bronchial Thermoplasty Published in the American Journal of Respiratory and Critical Care Medicine
Date:1/12/2010

Asthma Quality of Life Questionnaire (AQLQ) score. Safety was assessed by comparing the short and long-term (out to one year) safety profiles for both the active and sham treatment groups.

In addition to an improvement in quality of life as measured by an increase in average Asthma Quality of Life Questionnaire (AQLQ) score at 6, 9, and 12 months in the active compared to the sham group, there were also improvements in overall asthma control as demonstrated by the following key statistically significant clinical findings of the AIR2 Trial during long-term follow-up:

  • 32% reduction in asthma attacks
  • 84% reduction in emergency room visits for respiratory symptoms
  • 66% reduction in days lost from work/school or other activities due to asthma
  • 36% reduction in patients reporting worsening of asthma due to multiple symptoms

In the period immediately following bronchial thermoplasty, there was an expected increase and worsening of respiratory-related symptoms, which were of the type expected following bronchoscopy in patients with asthma. These events typically occurred within a day of the procedure and resolved on average within seven days with standard care. In the long term after treatment, fewer bronchial thermoplasty treated patients reported respiratory adverse events. The report in AJRCCM concluded that the increased risk of adverse events in the short-term following the procedure is outweighed by the benefit of bronchial thermoplasty that persists for at least one year.

In October of 2009, the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the Alair® System be found approvable with conditions based on the results of this and other studies. The application for FDA approval of the Alair System is presently under re
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SOURCE Asthmatx Inc.
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