SOURCE: Asthmatx

March 29, 2007 08:30 ET

New England Journal of Medicine Report Shows Improved Asthma Control One Year Following a New Outpatient Procedure for Asthma

Positive Study Results of Bronchial Thermoplasty, an Innovative Non-Drug Procedure for Asthma

MOUNTAIN VIEW, CA -- (MARKET WIRE) -- March 29, 2007 -- Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment of asthma, announced today the publication of positive results from its multicenter, randomized and controlled Asthma Intervention Research (AIR) Trial in the New England Journal of Medicine (NEJM). The publication, entitled "Asthma Control during the Year after Bronchial Thermoplasty," showed that patients treated with bronchial thermoplasty, as compared to a control group that did not receive the out-patient procedure, demonstrated a statistically significant:

--  decrease in asthma attacks,
--  reduction in rescue medication use (short-acting bronchodilators),
--  increase in days with no asthma symptoms,
--  improvement in pulmonary function (morning peak expiratory flow),
--  improvement in asthma-related quality of life, and
--  improvement in asthma control.
    
Further, the study showed that in the year after bronchial thermoplasty, compared to their baseline status, patients treated with the outpatient procedure demonstrated a:
--  50% decrease in asthma attacks, from 18/year to 9/year,
    
--  45% reduction in rescue medication use, from 20 puffs/week to 11
    puffs/week of short-acting bronchodilators,
    
--  2.6 fold increase in days with no asthma symptoms, from 3 months with
    no asthma symptoms to 8 months with no asthma symptoms,
    
--  Clinically significant improvements in both asthma quality of life and
    asthma control.
    
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 airway smooth muscle that narrows the airways in patients with asthma. The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.

An accompanying editorial in the same issue of the NEJM, entitled "Airway Smooth Muscle as a Target for Asthma Therapy," acknowledges that "the beneficial clinical effects suggested in the report by Cox and colleagues and in previous studies, highlights the potential usefulness of targeting airway smooth muscle in the treatment of asthma."

The objective of the AIR Trial was to examine the efficacy and safety of bronchial thermoplasty in patients with moderate to severe asthma. The trial included 112 patients between the ages of 18 and 65 at 11 centers in 4 countries, and followed these patients for one year after treatment. The primary outcome of the trial was to assess the difference between treated and untreated groups in the rate of asthma attacks. Data were collected to track asthma attacks, and to assess daily changes in lung function, asthma symptoms, and rescue medication use. An asthma attack consisted of at least one of the following occurrences on 2 consecutive days: reduction in morning peak expiratory flow of at least 20% below the average at baseline; need for more than 3 additional puffs of rescue medication than average; or awakening at nighttime due to asthma symptoms. Study patients remained on standard maintenance medications of inhaled corticosteroids over the course of the study.

One-year data from the trial demonstrated that treated patients, as compared to untreated control patients, experienced approximately 10 fewer asthma attacks per year, were free of their asthma symptoms an average of 86 additional days per year, and required 400 fewer puffs of their rescue medication. Further, as compared to the untreated group, the bronchial thermoplasty treated patients reported significant increases in their asthma-related quality of life and asthma control, as measured respectively by an improvement in the validated Asthma Quality of Life Questionnaire (AQLQ) and the Asthma Control Questionnaire (ACQ) scores.

In the period immediately following bronchial thermoplasty, there was an expected increase and worsening of respiratory-related symptoms such as breathlessness, wheeze, cough, chest discomfort, night awakenings, and productive cough. These symptoms were of the type expected following bronchoscopy in patients with asthma, and resolved on average within 7 days with either no therapy or with standard medical care. The frequency and types of respiratory-related adverse events were similar in both groups from 6 weeks after the treatment out to one year.

"This recent study shows that significant improvements in objective and patient-reported outcomes were persistent at one year. These results are consistent with our earlier research where we found the benefits of bronchial thermoplasty persisted out to two years," explains Gerard Cox, M.B., Professor of Medicine, McMaster University (Ontario, Canada) and Principal Investigator of the study. "These findings are very encouraging and mean that bronchial thermoplasty may be a new option for asthma patients who have asthma symptoms despite use of current drug therapies."

"We are very pleased with these trial results and what they suggest for the millions of patients whose asthma is not well-controlled by their existing medications," states Glen French, CEO of Asthmatx. "After nearly ten years of pre-clinical and clinical research, it is very encouraging that these data are so consistent with our earlier clinical experience, which was reported last May in the American Journal of Respiratory and Critical Care Medicine."

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 American Lung Association, more than 20 million Americans have asthma, and about two-thirds of these patients are adults. Managing unstable asthma consumes billions of dollars of healthcare resources each year. In the U.S. each year, asthma attacks result in approximately 10 million unscheduled doctor office visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 5,000 deaths.

Bronchial thermoplasty is an innovative non-drug procedure for asthma. An animated explanation of the procedure, a video clip of a bronchoscopic treatment procedure, and additional clinical data are given in the online supplement of the NEJM (www.nejm.org).

Current Research of Bronchial Thermoplasty

A total of approximately 250 patients have received the bronchial thermoplasty treatment to date in 4 clinical studies on patients with asthma. The longest follow-up is out to 5 years. More than 80 patients are currently past their 1-year follow-up, and over 50 patients are out to 2 years follow-up. Asthmatx will complete enrollment of approximately 300 patients in the AIR2 Trial, the fourth clinical study of the Alair Bronchial Thermoplasty System, later this year. If you have asthma, are between 18 and 70 years of age, are a non-smoker, and take medication daily to help control your asthma, you may be eligible to participate in a future bronchial thermoplasty clinical study. For more information on participation, please call the following toll-free number: (866) 400-2472 or visit www.bronchialthermoplasty.com.

CAUTION: Alair System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.

Alair is a registered trademark of Asthmatx, Inc.

Editor's Notes:

For more information on Asthmatx or the Alair Bronchial Thermoplasty System, please contact Karen Passafaro at 650-810-1118 or kpassafaro@asthmatx.com.

About Asthmatx:

Asthmatx is developing catheter-based medical devices for the treatment of asthma. Asthmatx has developed the Alair System to perform an investigational outpatient procedure called bronchial thermoplasty. Bronchial thermoplasty involves the delivery of precisely controlled thermal energy to the airway wall, to reduce the amount of airway smooth muscle, and lessen these muscles' ability to narrow the airway. The Alair System from Asthmatx was recently awarded "Best of 2006" by Popular Science Magazine and Bronchial Thermoplasty was named one of the "Top Ten Medical Innovations for 2007" by the prestigious Cleveland Clinic. For more information on Asthmatx visit www.asthmatx.com. The Alair System has received a CE Mark to sell the device in the European Union.

Contact Information

  • For more information, contact:
    Karen Passafaro
    650-810-1118
    Email Contact

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