Tuesday, May 19, 2009
Bronchial Thermoplasty Does Well in AIR2 Trial
Filed under: Medicine
, Thoracic Surgery
Asthmatx, Inc. of Sunnyvale, California, a developer of the Alair® bronchial thermoplasty device, designed to reduce the amount of smooth muscles in the airway walls of small to medium size airways, is reporting positive results from the Asthma Intervention Research 2 (AIR2) Trial. The system, reported by us on a couple of occasions before, uses a probe inserted into the lungs to deliver radiofrequency induced heat to reduce smooth muscle within airways. Bronchial thermoplasty, as the procedure is called, has been undergoing clinical trials in a bid to receive regulatory approval. The latest trial involved about 300 asthmatics and has shown that extreme asthma attacks were reduced by 32 percent in a select group of patients, and that 84 percent fewer trips to the emergency room occurred in the patient group.
More about Alair bronchial thermoplasty from Asthmatx website::
The AIR2 Trial was designed to evaluate the safety and effectiveness of bronchial thermoplasty in adult patients with severe asthma who were symptomatic, despite being treated with high doses of standard of care medications (high dose inhaled corticosteroids and long-acting bronchodilators). The study was a randomized, double-blind, sham-controlled trial and enrolled 297 patients at 30 sites in 6 countries. The primary effectiveness endpoint was the change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score. Safety was assessed by comparing the short and long-term safety profiles for both the treatment and sham control
groups.Key statistically significant clinical findings of the AIR2 Trial were:
Improvement in the average AQLQ score at 6-, 9-, and 12 months over sham control 4 out of 5 Alair-treated patients responded with a clinically significant improvement in AQLQ compared to 64% of sham controls 32% reduction in asthma attacks 84% reduction in emergency room visits for respiratory symptoms 36% reduction in patients reporting episodes of asthma (multiple symptoms) adverse events 66% reduction in days lost from work/school or other activities due to respiratory symptoms In the period immediately following bronchial thermoplasty, there is an expected increase and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within 7 days with standard care. In the long term, fewer bronchial thermoplasty treated patients reported respiratory adverse events and there was a significant decrease in patients reporting asthma (multiple symptoms) adverse events in the Alair-treated group compared to the sham control group.
"The results from AIR2, similar to the results from two prior randomized clinical trials evaluating the Alair System, demonstrate that patients with severe asthma can experience clinically significant improvements in their asthma control and their quality of life," said Glen French, CEO of Asthmatx.
The results of this pivotal study have enabled Asthmatx to submit a Premarket Approval application (PMA) to the FDA for regulatory approval. The FDA granted the Alair System PMA Expedited Review Status in October 2008, based on it's potential "to treat asthma, a lifethreatening/debilitating disease" and because the "Alair System offers a breakthrough technology which has the potential to address an unmet clinical need within the asthma
population."
System info page: Alair® System
Flashbacks: Alair System May Become Option for Asthmatics ; The Alair® System for Bronchial Thermoplasty™
Animation below the fold demonstrates the functionality of the procedure:
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examples: <b>Bold</b> <i>Italic</i>
