Asthmatx, a medical device company, has received FDA approval for Alair Bronchial Thermoplasty System for the treatment of severe asthma.
FDA approval of the Alair System was based on the results of the Asthma Intervention Research 2 (AIR2) Trial, a multicenter, double-blind, sham-controlled study designed to evaluate the safety and effectiveness of bronchial thermoplasty in adult patients with severe asthma.
The AIR2 Trial collected nearly 6GB of data and included 30 active sites spread across six countries. 297 adult patients were enrolled and the trial collected over 77,000 forms from 12 office visits and 31 phone contacts per patient. Case Report Form (CRF) design included 1869 edit specifications.
The trial demonstrated that patients treated with the Alair System improved their asthma quality of life. The result of the trial suggested 32% reduction in asthma attacks, 84% reduction in emergency room visits for respiratory symptoms, 73% reduction in hospitalisations for respiratory symptoms and 66% reduction in days lost from work/school or other daily activities due to asthma.
Narinder Shargill, vice president of clinical affairs at Asthmatx, said: “It was important for us to minimise the time from completion of the 12 month follow-up of all patients and the submission of our PMA. TrialMaster allowed us to accomplish this objective through efficient data entry and this accelerated our ability to lock the database and analyse the data.
“With TrialMaster, our database was locked within a few weeks. The TrialMaster system remains active as Asthmatx continues to follow its BT patients out 5 years in order to collect long-term safety data.”