Chronic asthma sufferers may find new relief in a simple, minimally invasive outpatient procedure known as bronchial thermoplasty, which uses controlled radiofrequency-generated heat to treat the muscles of the airways, preventing them from constricting and narrowing.
The study, which was approved by the Food and Drug Administration (FDA), marks the most recent phase of investigational trials of the Alair System, the device used in the bronchial thermoplasty procedure. If approved, it would become the first non-pharmaceutical therapy to effectively treat severe asthma.
Results of the multi-center study of Alair, which is manufactured by Asthmatx, will be presented on Monday, May 18, during the 105th International Conference of the American Thoracic Society in San Diego.
"The research we will be presenting was part of the pivotal clinical study designed for submission to the FDA, which provides evidence supporting the effectiveness and safety of the Alair system when used in the bronchial thermoplasty procedure," said lead author Mario Castro, M.D., M.P.H., professor of medicine and pediatrics at Washington University School of Medicine.
Researchers at 30 sites in six countries enrolled 297 patients with severe asthma to participate in the trial. Participants—all of whom continued to experience asthma symptoms, despite high doses of asthma medications—were split into two subgroups. Patients in the control group were randomly assigned to receive a placebo or "sham" treatment, meaning that while they underwent the procedure, no heat was applied. Researchers used a quality-of-life scale to measure the results at six months, nine months and one year. Overall, 79 percent of the patients in the experimental group who were treated with bronchial thermoplasty experienced a statistically significant and clinically meaningful improvement in their quality-of-life measurements.