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By radically changing the standard of care, Asthmatx will become the leading provider of therapeutic medical devices for patients who suffer from asthma.
FAQ
What is the AIR2 Trial?
The AIR2 Trial: The objective of this randomized, double blind, sham-controlled study is to evaluate the safety and efficacy of Bronchial Thermoplasty with the Alair® System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy.
Miller J, Cox G, Vincic L, et al, A Prospective Feasibility Study of Bronchial Thermoplasty in the Human Airway, CHEST 2005;127:1999-2006
A Prospective Feasibility Study of Bronchial Thermoplasty in the Human Airway*
John D. Miller, MD; Gerard Cox, MB; Lydia Vincic, MD; Charles M. Lombard, MD; Bryan E. Loomas and Christopher J. Danek, PhD
* From the Division of Thoracic Surgery (Drs. Miller, Cox, and Vincic), St. Joseph’s Healthcare, Hamilton, ON, Canada; Department of Pathology (Dr. Lombard), El Camino Hospital, Palo Alto CA; (Broncus Technologies (Mr. Loomas), Mountain View, CA; and Asthmatx Inc. (Dr. Danek), Mountain View, CA.
Abstract
Background: Bronchial thermoplasty is a novel procedure being developed as a potential treatment for asthma. Experience with animal studies has enabled development of appropriate reliable equipment, definition of therapeutic parameters, and descriptions of tissue effects of treatment.
Study Objectives: This study was undertaken to assess the feasibility and general safety of the application of bronchial thermoplasty in the human airway, and to determine if the reduction in airway smooth muscle seen in animal studies could be replicated.
Design: A prospective study.
Setting: Academic thoracic surgery center.
Participants: Nine patients scheduled to undergo lung resection for suspected or proven lung cancer.
Interventions: Bronchial thermoplasty was performed during routine preoperative bronchoscopy up to 3 weeks prior to prescheduled lung resection. Treatment was limited to areas of the segmental bronchi within the lobe that was to be removed. Treated airways were inspected via bronchoscopy at the time of thoracotomy, and were examined histologically following surgical resection.
Results: There were no adverse clinical effects of the procedure, including no new symptoms and no unscheduled visits for medical care. Treated sites exhibited slight redness and edema of the mucosa within 2 weeks of treatment, and appeared normal at later time points. There was narrowing (visually estimated at 25 to 50%) in four airways in two subjects examined at 5 days and 13 days after treatment, with excess mucus in two of these airways. There was no bronchoscopic evidence of scarring in any of the airways examined. Histologic examination showed a reduction in airway smooth muscle, and the extent of the treatment effect was confined to the airway wall and the immediate peribronchial region.
Conclusion: Application of bronchial thermoplasty to the human airway appears to be well tolerated. Treatment resulted in significant reduction of smooth muscle mass in the airways. Bronchial thermoplasty may provide therapeutic benefit in disease states such as asthma.
Key Words
airway smooth muscle • asthma • bronchial thermoplasty • bronchoscopy • human airway • radiofrequency • thermal coagulation
CAUTION: The Alair® System is an Investigational device.
It is limited by United States law to investigational use. To be used by Qualified Investigators only.
Alair, Asthmatx, and It's about breathing are trademarks or registered trademarks of Asthmatx, Inc.
Copyright © 2006, Asthmatx Inc. All Rights Reserved.
Last Updated: August 22, 2007
