Encouraging results for the use of bronchial thermoplasty procedure were reported by the Research in Severe Asthma (RISA) Trial , at the annual scientific assembly of the American Thoracic Society (ATS) by Neil Thomson,MD, Professor of Respiratory Medicine, University of Glasgow, Scotland. This announcement came from Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment of asthma.
Severe asthma patients who underwent bronchial thermoplasty showed significant improvements in asthma control, pulmonary function and quality of life. There was also lesser use of rescue medications. The novel, non-drug procedure is under clinical investigation in the United States.
The RISA Trial was conducted at a total of eight hospitals, in three countries, and evaluated the safety and efficacy of bronchial thermoplasty in 32 adult subjects with severe persistent asthma who remained symptomatic despite taking regular asthma medications.
Compared to patients who received only standard asthma medications, patients who received the bronchial thermoplasty procedure and standard medications showed clinically and statistically significant improvements in pulmonary function, quality of life, and asthma control, and used less rescue medication nearly 6 months following the procedure.
One year following the treatment, 50% of bronchial thermoplasty treated patients were able to wean completely off oral corticosteroids (OCS), compared to 14% of patients who did not receive the treatment. Further, a greater overall reduction in OCS dose was observed at 52 weeks in the bronchial thermoplasty treated patients compared with those that did not receive treatment at 52 weeks, although this difference didn't reach statistical significance. The study was not powered to show statistical significance in medication changes.
In this group of patients with severe asthma, an increase in respiratory-related symptoms, and hospitalizations related to these symptoms, were expected and observed during the period immediately following the procedure. These symptoms were of the type expected following bronchoscopy in patients with asthma, and they resolved on average within seven days.
"Following bronchial thermoplasty, patients with severe, refractory asthma demonstrated significant improvements in pulmonary function and asthma control," states Dr. Thomson. "These significant and seemingly long-lasting improvements came at the cost of a short-term increase in hospitalizations, but the apparent benefits seem to be greater than the manageable consequences of the procedure."
"The results from this randomized, controlled, multi-center trial provide some hope for patients with severe, refractory asthma - people who despite taking state-of-the-art medications are still experiencing the disruptive and distressing symptoms of their asthma," states Glen French, CEO of Asthmatx, Inc. "We were particularly encouraged by the data that suggested that patients may be able to reduce their oral steroid dose and still maintain their asthma control."