Asthmatx, Inc. has announced the publication of data from the Research in Severe Asthma (RISA) Trial of bronchial thermoplasty in the American Journal of Respiratory and Critical Care Medicine (AJRCCM, 2007; 176:1185-1191).
The publication reports that despite a transient increase in procedure related adverse events, patients experienced longer term improvement in pulmonary function, improved quality of life and asthma control, and a reduction in rescue medication use for patients treated with bronchial thermoplasty.
Bronchial thermoplasty is a non-drug treatment for asthma and is currently under clinical investigation. 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.