ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today introduced an advanced respiratory clinical trial solution to centrally capture, measure and analyze Lung Clearance Index data, in near real-time, to assess lung performance with more precision than traditional spirometry measures.
LCI ─ a measure of lung physiology derived from multiple breath washout tests ─ is a valuable endpoint because of its sensitivity to small airways’ dysfunction. The test enables researchers to detect disease progression more accurately than via spirometry endpoints such as FEV1 in early stage cystic fibrosis, early COPD, mild asthma and other indications.
By integrating the EasyOne Pro® LAB device from ndd® into ERT’s EXPERT® technology platform, ERT’s Centralized LCI Services improve data quality and protocol compliance while reducing patient and investigative site burden. Clinical trial sponsors benefit from ERT’s well-recognized project management, data management, and training programs, as well as real-time site quality alerts and critical oversight that optimize LCI data collection and analysis.
“ERT has a rich heritage of innovating respiratory data solutions that help our customers meet their development objectives,” said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT. “In the early stages of lung disease, spirometry values often do not show abnormalities as the larger airways are not yet affected, and this is where LCI is useful. We’re expanding our proven solution set to give sponsors better options for evaluating this endpoint with greater confidence.”
Demonstrations of ERT’s Centralized LCI Services, as well as enhancements to its AM3G+™ home spirometer/eDiary and SpiroSphere® ─ ERT’s patent-pending, next generation spirometer ─ will be available in booth 1443 at the American Thoracic Society’s (ATS) International Conference beginning May 22 in Washington, DC.
For more information on ERT’s centralized respiratory solutions and services, visit ERT.com/respiratory.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn and Twitter.