PHILADELPHIA, PA — Strados Labs announced it has partnered with Ann & Robert H. Lurie Children’s Hospital of Chicago for a clinical trial to evaluate the effectiveness of its RESP™ Biosensor in children presenting with wheeze. The RESP™ Biosensor – a novel wearable device used to remotely monitor lung sounds for asthma symptoms such as coughing and wheezing – will be evaluated against a 3M™ Littman digital stethoscope used for episodic auscultation.
Pediatric asthma affects more than 5 million children each year with 1 in 6 children visiting the emergency room annually due to complications, according to the CDC. There is an urgent need for improved methods to detect and prevent exacerbations while patients are at home, particularly when asthma symptoms have become severe enough to warrant an ER visit or hospital admission. This study aims to leverage Strados Labs’ RESP Biosensor, which has FDA clearance for use in adults, to potentially enhance the management of pediatric asthma and prevent hospitalizations.
Lurie Children’s, the Midwest’s largest freestanding children’s hospital, and its research enterprise, Stanley Manne Children’s Research Institute, are dedicated to reducing childhood morbidity associated with respiratory conditions, including asthma. Dr. Henry Schmidt and Lurie Children’s have established an innovative collaborative partnership with Strados Labs to address a critical care gap in pediatric asthma management. Enrollment for the study began in August of 2023.
“We are thrilled to begin enrolling patients in this study in conjunction with Strados Labs,” said the study principal investigator Dr. Henry Schmidt. “This validation research represents an important steppingstone to further projects and ultimately clinical application of the RESP Biosensor. I feel that this technology represents an objective way to measure lung health in a safe, noninvasive format that is appealing to pediatric medicine. Utilizing this technology also has the potential to advance pulmonary diagnostics in a way that addresses healthcare disparities in our communities through improved access to care.”
The outcomes of this research will influence a follow-up study focusing on hospitalized children with asthma. This subsequent study will evaluate if the RESP Biosensor and the Strados™ Respiratory Care Platform can help determine readiness for reduction or escalation of therapy compared to current standard of care.
“From my experience as a former asthma patient, going home after an event can be scary and unsettling,” said Nick Delmonico, Co-founder & CEO at Strados Labs. “Having a tool that allows clinicians to objectively monitor symptoms such as coughing and wheezing against the care plan can offer patients and families a greater sense of security and reduce the risk of hospitalizations in the future.”