SAN DIEGO — The Alair Bronchial Thermoplasty System produced significant improvements in quality of life in 79% of patients with severe asthma who underwent treatment, compared with 64% of sham controls, results from a randomized, multicenter pivotal trial demonstrated.

Moreover, patients in the treatment group had a 32% reduction in asthma attacks, an 84% reduction in emergency room visits for respiratory symptoms, and a 66% reduction in days lost from work, school, or other activities due to respiratory symptoms.

The findings exceeded the expectations of principal investigator Dr. Mario Castro, professor of medicine and pediatrics at Washington University, St. Louis. “These patients were getting maximal treatment with the standard of care,” Dr. Castro said during an interview at an international conference of the American Thoracic Society, where the work was presented. “Beyond that we were able to get a marked improvement in quality of life, health care utilization, and days lost from school or work. Those are meaningful end points for our patients.”

One of the patients Dr. Castro treated was a long-distance runner who had been sidelined because of the severity of his asthma. After undergoing bronchial thermoplasty he returned to running and went on to compete in a marathon.

“You can't get more of a testament than that,” he said.

Developed by Asthmatx Inc. of Sunnyvale, Calif., the Alair Bronchial Thermoplasty system is an investigational device that delivers radiofrequency energy to the airway walls during a bronchoscopic procedure in an effort to reduce the amount of airway smooth muscle.

The procedure, which takes 30–45 minutes to perform, is not designed to replace standard of care therapy, Dr. Castro said, but rather as “an add-on treatment we can do once patients are not achieving good control with the standard of therapy. It's nice to have something else to look forward to with these patients, because they come to your office and they're really desperate for something new in treatment.”

After their first treatment patients return for two additional bronchoscopic treatments spaced 2–3 weeks apart. “It's definitely a time commitment in terms of getting the treatment, recovering, and getting the two additional treatments,” noted Dr. Castro, who also directs Washington University's Asthma and Airway Translational Research Unit. “But you compare that to having to take a drug every day for the rest of your life, it's a small investment.”

The Alair System has received a CE mark for use in the European Union. In the United States a premarket approval application has been submitted to the Food and Drug Administration, which is expected to review the application this summer.

The purpose of the Asthma Intervention Research 2 (AIR2) trial was to evaluate the safety and effectiveness of the Alair System in 297 patients with severe asthma at 30 centers in six countries who were symptomatic despite being treated with high doses of inhaled corticosteroids and long-acting bronchodilators.

The trial was randomized, double blind, and sham controlled, and the primary effectiveness end point was significant improvement from baseline in Asthma Quality of Life Questionnaire (AQLQ) score.

Of the 297 patients 196 received bronchial thermoplasty while 101 received a sham bronchoscopy in which no radiofrequency energy was applied. The average age of patients was 41 years, and more than half were female.

Dr. Castro reported that 79% of patients in the treatment group had significant clinical improvements in their average AQLQ scores at 12 months, compared with 64% of patients in the sham group, a difference that was statistically significant.

Compared with patients in the sham group, patients in the treatment group had a 32% reduction in asthma attacks, an 84% reduction in emergency room visits for respiratory symptoms, a 36% reduction in patients reporting asthma (multiple symptoms) as an adverse event, and a 66% reduction in days lost from work, school, or other activities caused by respiratory symptoms.

If the Alair system is approved for use, Dr. Castro expects a significant impact on the pulmonology field.

“This is a new treatment for a lung disease that is very common, so our field is going to have to get comfortable with this new device and new treatment,” he commented.

“I think it's going to have a significant impact on how pulmonologists are trained on this new device. If this gets approved there will be a need for training workshops so that physicians are comfortable with its use. I think it's going to have a profound impact on our care of these patients with disabling asthma.”

While the cost of the procedure will vary by practice setting, he expects it to be in the ballpark of a bronchoscopy.

Dr. Castro disclosed that he is a paid consultant for Asthmatx, which funded the study.

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There was marked improvement in patients who were already 'getting maximal treatment with the standard of care.' DR. CASTRO

Bronchial Thermoplasty Demonstrates Efficacy : Experimental radiofrequency energy system reduced asthma attacks by 32%, ED visits by 84%.