ERT, a global data and technology company that minimises uncertainty and risk in clinical trials, has introduced an advanced respiratory clinical trial solution to centrally capture, measure and analyse 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 Centralised LCI Services improve data quality and protocol compliance while reducing patient and investigative site burden.
Clinical trial sponsors benefit from ERT’s well-recognised project management, data management and training programmes, 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.”