AIR2 Clinical Trial Begins at Baptist Hospital West; Study to Focus on Treatment That May Change the Face of Asthma Care.

KNOXVILLE, Tenn. -- Baptist Hospital West in Knoxville is the only site in Tennessee participating in an international, multi-center clinical trial to treat Asthma, a serious health issue that affects over 20 million people in the United States alone. Currently the only treatment for Asthma is medication and there is no cure. AIR2 (Asthma Interventional Research) will explore a new outpatient investigational procedure called bronchial thermoplasty to treat asthma. This minimally invasive procedure reduces the amount of airway smooth muscle that is responsible for the constriction of airways in Asthma patients.

Asthma attacks are largely due to a hyperresponsive (hypersensitive) airway that narrows excessively when the muscle fibers, or "airway smooth muscle," located in the airway wall contract. This constriction is a major contributor to airflow obstruction in asthma attacks.

During the trial, physicians will actually go into the airways with a flexible bronchoscope, which is a routine procedure, and by generating and applying thermal energy with a new investigational medical device, will reduce areas of underlying smooth muscle in the small to medium size airways. The Alair(R) System - which is manufactured by Asthmatx, Inc. - consists of a single-use device and a controller that generates thermal energy to apply heat to the bronchial wall during an outpatient bronchoscopic procedure known as bronchial thermoplasty.

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 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 and narrow and spasm in response to irritation, infection, or inflammation.

One of the first research sites that began the study in the US, and the only site in Tennessee, is Baptist Hospital West in Knoxville. "The smooth muscle in your airway serves no real purpose. It's kind of like your appendix," explains Matthew Sellers, MD, an interventional pulmonologist and Principal Investigator of the study at Baptist Hospital West. "But when something does go wrong with it, it can cause problems. It can spasm and constrict the airway considerably, causing real health consequences for asthmatics. By reducing the amount of airway smooth muscle with the Alair System, the ability of the airway wall to spasm and constrict should be reduced."

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.

The procedure is performed in a medical suite and takes about an hour to complete, followed by post-procedure observations for approximately 4 hours. This is done as an outpatient procedure with conscious sedation. No incision is made, no general anesthesia is necessary, and there is no need to stay overnight.

Approximately 300 patients will participate in the trial, which is being conducted at various sites around the world. If you or someone you know has Asthma is between 18 and 65 years of age, takes daily medication for asthma, and are non-smoker, you may be eligible to participate in this study. For more information on the study visit http://www.clinicaltrials.gov. Patients can be referred directly to 865-549-4553.