Positive results from post approval clinical trial evaluating bronchial thermoplasty (PAS2) of Alair System in severe persistent asthma .- Boston Scientific.

Boston Scientific announced positive results from the Post Approval Clinical Trial Evaluating Bronchial Thermoplasty (BT) in Severe Persistent Asthma (PAS2) study evaluating patients treated with the Alair System. The data, presented at the American Thoracic Society International Conference in Washington, D.C., demonstrate that BT reduces complications in adult patients with severe persistent asthma.

PAS2 is an open-label study that enrolled 284 patients at 27 research centers in the United States and Canada. Study participants have asthma that is not well controlled by inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) and may also rely heavily on additional maintenance medications including oral corticosteroids (OCS) and biologics. At the beginning of the study, PAS2 study participants were, on average, 45.7 years old with a body mass index of 32.2 kg/m2, took mean ICS and LABA doses of 2275 �g/day and 106 �g/day, respectively, with 19.4 percent utilizing OCS and 15.8 percent omalizumab. These measures are significantly higher than in prior studies.

Overall, patients in the study showed marked clinical improvement that was sustained for two years following treatment. The data demonstrated that: 1.The percentage of study participants that had at least one severe asthma exacerbation decreased from 77.8 percent in the year prior to treatment to 50.4 percent in year one and 46.4 percent in year two; 2.The percentage of patients who had asthma-related hospitalizations decreased from 16.1 percent in the year prior to BT to 8 percent and 7.3 percent in years one and two following treatment; 3.The percentage of patients with asthma-related ER visits reduced from 29.4 percent in the year before BT to 18.3 percent and 14.5 percent in years one and two post-BT; By the second year following BT treatment, the percentage of patients taking OCS to manage their asthma symptoms had decreased by 39.2 percent from 19.4 percent pre-treatment to 11.8 percent. PAS2 study participants will be followed for five years post treatment to conduct further analysis.

Comment: The Alair System for BT was approved by the FDA in 2010 and is the first non-pharmacologic, device-based treatment for severe, persistent asthma. The Alair System delivers controlled thermal energy to the airway wall to reduce the amount of excess smooth muscle tissue in the airways. With less smooth muscle, the airways constrict less, reducing severe asthma attacks and making breathing easier.