December 27, 2006
Veritas Clinical Specialties to Study New Investigational Outpatient Procedure for Asthma
Researchers at Veritas Clinical Specialties today announced the start of the AIR2 (Asthma Interventional Research) international, multi-center clinical trial to explore a new investigational asthma treatment that may significantly change the course of asthma care. The study, which will take place at St. Francis Health Center, focuses on a procedure called Bronchial Thermoplasty to treat asthma. This procedure uses thermal energy to reduce the amount of smooth muscle in the airway that contributes to the constriction during an asthma attack. Early patient data from trials outside the United States suggest it may hold promise for moderate and severe asthmatic patients.
"Currently medication is the only treatment option for asthma and for many it does not alleviate their symptoms effectively," explains William Leeds, DO, an interventional pulmonologist at Veritas Clinical Specialties and principal investigator of the study. "This outpatient procedure looks to reduce asthma symptoms by targeting the muscle that constricts during an asthma attack."
Asthma is a disease involving greater than normal responsiveness of airways in the lungs to a variety of stimuli. This increased responsiveness can take the form of swelling of the airway wall, excess mucus production that can clog the airways, and significant narrowing of the airways when tiny muscles in the airway wall, called "airway smooth muscle", contract.
During Bronchial Thermoplasty, an outpatient bronchoscopic procedure, physicians will use the AlairÃ® System to go into the airways with a flexible bronchoscope through the nose or the mouth and deliver thermal energy to the airway walls in an effort to reduce the presence of airway smooth muscle.
"The thermal energy that is applied to the airway through this procedure reduces the amount of muscle in the airway walls which reduces the ability for it to constrict. Less constriction in the airways may result in reducing the severity and frequency of asthma symptoms. This could have a significant impact on how we manage asthmatic patients in the future," explains Dr. Leeds.
During the clinical trial, physicians will treat one-third of the lungs in each treatment session for a total of three treatment sessions. The procedure is performed in a medical suite and takes about an hour to complete, followed by post-procedure observations for approximately 4 hours. The procedure will be performed as an outpatient procedure under conscious sedation. No general anesthesia is used, no incision is necessary, and there is no need to stay overnight. Also, patients who are currently highly medicated will stay on their medication for the duration of the study.
The researchers are careful to point out that there is no expectation that this new investigational procedure will cure asthma. However, it is hoped that this procedure could be useful in reducing the severity and frequency of asthma symptoms and improving quality of life for patients with asthma. Thus, Bronchial Thermoplasty may become one of the many treatments that are available for the management of asthma.
Asthma is one of the most common and costly diseases in the world. It affects more than 20 million people just in the U.S.; with an estimated 2 million emergency room visits, and 5,000 deaths per year. The prevalence of asthma is on the rise, and there is no cure.
Dr. Leeds anticipates enrolling up to 20 patients at as part of the 300 patient trial being conducted at various sites around the world. If you have asthma, are between 18 and 65 years of age, take medication daily to control your asthma, and are a non-smoker, you may be eligible to participate in this study. For more information on participation in this study please call 866-400-AIR2.
About the Alair System
The Alair System -- which is manufactured by Asthmatx, Inc. -- consists of a single-use device and a controller that delivers thermal energy to apply heat to the bronchial wall.
The system consists of a catheter with an expandable wire basket at the tip. The four arms of the expanded basket come in contact with and fit snugly against the airway wall. The expanded basket then delivers controlled thermal energy for about 10 seconds to heat the airway smooth muscle. A contiguous series of thermal energy applications are needed to treat along the accessible length of the airways. Once the treatment session is completed, the device and the bronchoscope are removed. The controlled heat is designed to reduce the amount of airway smooth muscle in the airway wall, thereby reducing the ability of the airway walls to contract, narrow and spasm in response to irritation, infection, or inflammation.
The Alair System has been used successfully in 16 patients with asthma who were enrolled in a safety trial at two asthma centers in Canada. Two years following their last treatment, the 16 patients on average showed less airway narrowing after stimulation with a drug that causes contraction of airway smooth muscle. All patients surveyed indicated that they would be willing to undergo the Bronchial Thermoplasty procedure again, knowing now what the procedure involves. An additional 70 patients with moderate to severe asthma have been treated with this device in subsequent randomized clinical studies conducted outside the US (Canada, Brazil and Europe), and are continuing to be evaluated.
NOTE: The Alair System is an Investigational device. It is limited by Federal (United States) law to investigational use. To be used by Qualified Investigators only.
To schedule an interview with Dr. Leeds, please contact Meghan Oreste at 617-823-1441 or [email protected]
For more information on the Alair System or Asthmatx, please contact Karen Passafaro at 650-810-1100 x118 or [email protected]
For questions about enrolling in the trial call 1-866-400-AIR2. For more information on the AIR2 trial, go to: www.AIR2Trial.com
Dr. Leeds has no financial interest in Asthmatx. The study is sponsored by Asthmatx.
About Veritas Clinical Specialties:
Veritas Clinical Specialties is a dedicated research site started in 2003. Veritas is associated with Pulmonary and Sleep Associates, which includes a state-of--the-art Accredited Sleep Center. Medical staff includes 3 physicians specializing in Pulmonary, Critical Care and Sleep Medicine.
Asthmatx is developing catheter-based medical devices for the treatment of asthma, a disease that affects over 20 million people in the United States. Asthmatx has developed the AlairÃ® System to perform an 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 results of three clinical studies of the Alair System suggest the procedure may offer significant benefits to patients with severe asthma.