OmniComm's EDC System Supports Asthmatx in Gaining FDA Approval of Groundbreaking Asthma Treatment
TrialMaster(R) EDC Solution Used for Collecting, Managing and Reporting Pivotal Study Data
FORT LAUDERDALE, FL, May 18, 2010 (MARKETWIRE via COMTEX) -- OmniComm Systems, Inc. /quotes/comstock/11k!omcm (OMCM 0.19, 0.00, 0.00%) , a global provider of eClinical solutions, announced that long-time customer, Asthmatx, Inc., Sunnyvale, Calif., received U.S. Food and Drug Administration (FDA) approval of its Alair(R) 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 Alair System is the first device-based asthma treatment approved by the FDA.
Asthmatx, a privately held medical device company committed to helping people with asthma, chose OmniComm's TrialMaster EDC and Trial Management solution in 2005 to help fill its data collection, management and reporting needs. "OmniComm is delighted to have shared in the success of one of our oldest tenured customers," said Stephen Johnson, chief operating officer of OmniComm Systems. "We are thrilled for Asthmatx and for this new treatment option for those that suffer with severe asthma." The AIR2 Trial collected nearly 6GB of data and included 30 active sites spread across six (6) countries. Two hundred ninety seven (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.
Not only did the trial demonstrate that patients treated with the Alair System improved their asthma quality of life over patients who rely solely on medical therapy after one year, but these patients also experienced other clinically significant benefits, including:
-- 32 percent reduction in asthma attacks
-- 84 percent reduction in emergency room visits for respiratory symptoms
-- 73 percent reduction in hospitalizations for respiratory symptoms
-- 66 percent reduction in days lost from work/school or other daily
activities due to asthma
According to David Templeton, Manager, Clinical Operations & Information Technology at Asthmatx, "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 (PHT Corporation, Charlestown, MA) and allow for on demand extraction of the data files by the Data Manager at QST Consultations, Ltd (Allendale, MI). 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, PhD., Vice President of Clinical Affairs at Asthmatx, further stated, "It was important for us to minimize 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 analyze the data." Dr. Shargill added, "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.
About Bronchial Thermoplasty Delivered by the Alair System Bronchial thermoplasty is a bronchoscopic procedure for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. Bronchial thermoplasty is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient's nose or mouth, and into their lungs. The tip of the small diameter Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of excess airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under moderate sedation and the patient typically returns home the same day. For more information on bronchial thermoplasty visit www.BTforAsthma.com.
About Asthmatx, Inc. Based in Sunnyvale, Calif., Asthmatx is a privately-held medical device company that designs, develops and manufactures catheter based medical devices incorporating thermal energy for patients with severe asthma. Asthmatx's first offering, bronchial thermoplasty delivered by the Alair System, is a novel device-based treatment option for patients with severe asthma. The Alair System has been approved for use in the U.S. by the FDA and has received a CE Mark for use in the European Union. For more information on Asthmatx visit www.asthmatx.com.
Alair, Asthmatx and the Asthmatx logo are registered trademarks of Asthmatx, Inc.
OmniComm Systems, Inc. (www.OmniComm.com) provides customer-driven Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct life changing clinical trial research. OmniComm's growing base of satisfied customers is a direct result of the company's commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComm's pricing model is easily understood and allows companies ranging from small, to large, to maximize their clinical research investments. OmniComm Systems, Inc. has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey and the United Kingdom, as well as sales offices throughout the U.S. and Europe.
Safe Harbor Disclaimer Statements made by OmniComm included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as the Company's ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the Company's financial results can be found in the Company's Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
CONTACT: Stephen Johnson at: + 1 954-377-1726
OmniComm Systems, Inc.
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SOURCE: OmniComm Systems, Inc.