FDA Approves Asthmatx Alair Bronchial Thermoplasty System: OmniComm Systems

Asthmatx chose OmniComm’s TrialMaster EDC and Trial Management solution in 2005 to help fill its data collection, management and reporting needs.

Stephen Johnson, chief operating officer of OmniComm Systems, said: OmniComm is delighted to have shared in the success of one of our oldest tenured customers. We are thrilled for Asthmatx and for this new treatment option for those that suffer with severe asthma.

OmniComm said that the 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 Alair System is the first device-based asthma treatment approved by the FDA.

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.

David Templeton, manager of clinical operations and information technology at Asthmatx, said: There were many unique aspects to this study, including the deployment of 2 separate study teams at each center (an unblinded Bronchoscopy Team that delivered the treatment, and a blinded Assessment Team that evaluated the patients post-treatment out to one year).

“The ability of TrialMaster to allow for controlled access to case report forms to both the study teams while maintaining the study blind was an important factor in our consideration of an EDC system. Additionally, the system was required to import data from electronic daily diaries maintained by study subjects and allow for on demand extraction of the data files by the Data Manager at QST Consultations.

“From a sponsor perspective, the vast amount of data collected was readily viewable in real time and made monitoring very efficient. Training of the study teams at each clinical center was easy to accomplish and the ease of understanding and using TrialMaster was appreciated by our study coordinators.

Narinder Shargill, vice president of clinical affairs at Asthmatx, said: TrialMaster allowed us to accomplish this objective through efficient data entry and this accelerated our ability to lock the database and analyze 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.