FDA Approves First Non-Drug Treatment for Severe, Persistent Asthma

Yael Waknine

April 28, 2010

April 28, 2010 — The US Food and Drug Administration (FDA) has approved the first device-based treatment for the treatment of severe and persistent asthma (Alair Bronchial Thermoplasty System; Asthmatx, Inc) in adults who remain symptomatic despite treatment with standard-of-care medications such as high-dose inhaled corticosteroids and long-acting beta agonists.

Bronchial thermoplasty is performed via the working channel of a standard bronchoscope inserted under moderate sedation through the nose or mouth into the lungs. Radiofrequency signals generated from a controller unit are delivered to the wire basket at the top of the catheter, where they are converted into heat that warms the lining of targeted airways.

Controlled administration of thermal energy to the lungs serves to reduce the amount of smooth muscle that narrows the airways in asthmatic patients, potentially decreasing the severity and frequency of asthma symptoms.

"The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in an agency news release.

FDA approval was primarily based on data from the sham-controlled Asthma Intervention Research 2 (AIR2) clinical trial of 297 patients at 30 sites in 6 countries [1]. The primary efficacy endpoint was the difference between baseline Asthma Quality of Life Questionnaire (AQLQ) scores and those at 6, 9, and 12 months (integrated AQLQ).

Results showed that 79% of patients in the thermoplasty group achieved significant improvements in average AQLQ score compared with 64% of the sham controls.

Thermoplasty also yielded a 32% decrease in asthma attacks, an 84% decrease in emergency department visits for respiratory symptoms, a 66% decrease in days lost from work/school or other activities because of asthma, and a 36% decrease in patients reporting worsening of asthma resulting from multiple symptoms.

"Bronchial thermoplasty decreases severe exacerbations and [emergency department] visits for respiratory symptoms and improves quality of life in patients with severe asthma," said Mario Castro, MD, in a company news release. "Bronchial thermoplasty with the Alair System offers clinicians a novel adjunctive therapy option, beyond the current use of inhaled corticosteroids and long acting beta agonists, to provide improvements in overall asthma control."

Dr. Castro is professor of medicine and pediatrics at the Washington University School of Medicine, St. Louis, Missouri, and served as a principal investigator in the AIR2 trial and lead author of the published study.

Although bronchial thermoplasty is designed to decrease the number of severe asthma attacks on a long-term basis, the procedure may cause a transient increase and worsening of respiratory-related symptoms that generally resolves within 7 days, using standard care. Other potential adverse effects may include atelectasis, hemoptysis, anxiety, headaches, and nausea.

The FDA warns that the device should not be used in patients with a pacemaker, internal defibrillator, or other implantable electronic device, or in those with known sensitivities to lidocaine, atropine, or benzodiazepines.

Bronchial thermoplasty is likewise contraindicated in the presence of active respiratory infection, coagulopathy, asthma exacerbations, and recent (<2 weeks) changes in corticosteroid regimens. Patients should not be retreated in the same area of the lung until further studies are conducted to assess whether retreatment is feasible.

More information about the device is available on the FDA Web site.

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