Monday, February 11, 2008
Alair System May Become Option for Asthmatics
Filed under: Medicine
, Thoracic Surgery
Asthmatx, Inc., the company developing the Alair® bronchial thermoplasty device to treat asthmatic patients, has released positive results of a latest multi-center study of the procedure.
Bronchial thermoplasty is an investigational procedure in which precisely controlled thermal energy is delivered with a tiny catheter to targeted airway walls of patients with asthma. This procedure is intended to reduce muscle in the walls of airways, and thereby decrease the ability of airways to narrow in patients with symptomatic asthma.The RISA Trial was a randomized trial conducted at a total of eight centers in three countries, and evaluated the safety and efficacy of bronchial thermoplasty in a total of 32 adult subjects, randomized 1:1 between the BT group and Control group with severe persistent asthma who were symptomatic despite taking regular asthma medications.
In this group of patients with severe asthma, an increase in respiratory-related symptoms was expected and observed during the period immediately following the procedure. Most occurred within one day of the procedure and resolved on average within a week. Following the treatment period, respiratory-related symptoms were similar between treatment groups.
Almost 6 months after the procedure, compared to the control group, patients who received bronchial thermoplasty showed clinically and statistically significant improvements in pulmonary function, quality of life and asthma control. In addition, patients in the treatment group used an average of 25 fewer puffs per week of rescue medication than those in the untreated Control group.
All patients then attempted to reduce their inhaled and/or oral corticosteroids (OCS) during a 14-week period. Fifty percent (50%) of bronchial thermoplasty treated patients were able to wean completely off their oral corticosteroids (OCS), compared to 14% of patients who did not receive the treatment. This improvement did not reach statistical significance; however the study was not powered to show statistical significance in medication changes.
One year following treatment, and after the period of medication reduction, patients who received the bronchial thermoplasty procedure continued to show clinically and statistically significant improvements in quality of life and asthma control, and used less rescue medication.
Press release: One-Year Results of Bronchial Thermoplasty in Refractory Asthma
Technology page: Bronchial Thermoplasty
Flashback: The Alair® System for Bronchial Thermoplasty™
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