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.