Asthmatx Inc., presented positive five-year data from the Asthma Intervention Research (AIR) Trial, which evaluated the safety of bronchial thermoplasty (BT) with the Alair® System. The data demonstrated the absence of clinical complications and the maintenance of stable lung function over a five year period post-BT in patients with moderate to severe asthma. The data was presented in a poster at the annual meeting of the American Thoracic Society (ATS) in New Orleans.
“With the addition of this new long-term data, I can now confidently tell my patients whose disease is poorly controlled, despite receiving the highest doses of standard asthma medications, that the procedure has demonstrated a stable safety profile for at least five years,” stated Dr. Gerard Cox, Professor of Medicine, McMaster University (Ontario, Canada) and lead author of the poster. “The present findings from the AIR Trial echo data from other controlled trials that demonstrated BT is safe and beneficial for these patients in the first year after treatment.”
The data showed that over five years:
– The percent of patients reporting respiratory adverse events remained stable
– Hospitalizations and emergency room visits for respiratory symptoms remained stable
– Pulmonary function (FEV1) remained stable
– No incidences of pneumothorax, intubation, mechanical ventilation, cardiac arrhythmias or death as a result of BT treatment over the five year follow-up
BT, which is the first device-based asthma treatment approved by the U.S. Food and Drug Administration (FDA), is a novel outpatient procedure that delivers precisely controlled thermal energy to reduce excess airway smooth muscle that is associated with airway constriction in patients with asthma. By decreasing the ability of the airways to constrict, this new treatment has been shown to help patients with severe asthma gain substantially better control over their disease.
In the period immediately following BT, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, which were of the type expected following bronchoscopy in patients with asthma. These events typically occurred within a day of the procedure and resolved on average within seven days with standard care.
The AIR Trial was a multicenter, randomized, controlled clinical study that evaluated the safety and effectiveness of BT in patients with moderate to severe asthma. Positive safety and effectiveness data at one year post-BT were published in the New England Journal of Medicine (NEJM) in March 2007. BT-treated patients have been followed for five years post-procedure to evaluate longer-term safety.
“This demonstration of long-term safety, combined with the therapeutic benefits demonstrated in a series of three randomized controlled clinical studies, is extremely uncommon for a medical device at the time of FDA approval,” said Glen French, CEO of Asthmatx. “It provides strong support for the adoption of BT as a new therapeutic option for the treatment of severe asthma in adults.”
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the Asthma and Allergy Foundation of America (AAFA), more than 20 million Americans have asthma, and managing asthma consumes over $18 billion of healthcare resources each year. In the U.S. each year, asthma attacks result in approximately 10 million outpatient visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 4,000 deaths.
About Bronchial Thermoplasty Delivered by the Alair System
The Alair® Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. The Alair® System is not for use in patients with an active implantable electronic device or known sensitivity to medications used in bronchoscopy. Previously treated airways of the lung should not be retreated with the Alair® System. Patients should be stable and suitable to undergo bronchoscopy. The most common side effect of BT is an expected transient increase in the frequency and worsening of respiratory-related symptoms.
Bronchial thermoplasty is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient’s nose or mouth, and into their lungs. The tip of the small diameter Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of excess airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under moderate sedation, and the patient returns home the same day.
Based in Sunnyvale, Calif., Asthmatx is a privately-held medical device company that designs, develops and manufactures catheter based medical devices incorporating thermal energy for patients with severe asthma. Asthmatx’s first offering, bronchial thermoplasty delivered by the Alair System, is a novel device-based treatment option for patients with severe asthma. The Alair System has been approved for use in the U.S. by the FDA and has received a CE Mark for use in the European Union.
Alair, Asthmatx and the Asthmatx logo are registered trademarks of Asthmatx, Inc.
Source: Asthmatx Inc