ResApp Health Limited (ASX: RAP) today announced that it is has received its first institutional review board (IRB) approval for the SMARTCOUGH-C study, a prospective, multi-site, double blind study that will evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood pneumonia and other respiratory conditions from cough sounds.
Three US hospital sites are participating in the study, including Cleveland Clinic, which is the first to secure institutional review board (IRB) approval to enrol patients.
The primary endpoints for the study will be the diagnosis of pneumonia with secondary endpoints being diagnosis of other common childhood respiratory diseases such as upper respiratory tract infection, croup, bronchiolitis and asthma. Today, respiratory disease diagnosis is based on a combination of auscultation, imaging and laboratory tests. An instant, accurate diagnostic test delivered via smartphone could greatly improve patient management, give greater access to healthcare and reduce costs.
Worldwide, pneumonia is the leading cause of death of children under 5 years of age and is the most common reason for US children to be hospitalised.
The Principal Investigator at Cleveland Clinic will be Dr. John Carl MD, Director of the Center for Pediatric Pulmonary Medicine.
“We are very pleased to announce that we have received our first IRB approval for our pivotal US pediatric study,” said Tony Keating, Managing Director and CEO of ResApp. “Our ultimate goal is to demonstrate the clinical accuracy of ResAppDx and improve healthcare for children everywhere.”
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About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a digital health company developing smartphone applications for the diagnosis and management of respiratory disease. The technology is based on machine learning algorithms that use sound alone to diagnose and measure the severity of respiratory conditions without the need for additional hardware. The algorithms were initially developed by The University of Queensland with funding from the Bill and Melinda Gates Foundation. ResApp has both adult and paediatric clinical studies underway with preliminary results demonstrating accurate diagnosis of pneumonia, asthma/viral wheeze, bronchiolitis, croup and upper respiratory tract infections in children as well as chronic obstructive pulmonary disease, asthma and pneumonia in adults. Markets for ResApp’s technology include telehealth use through partnerships with telehealth service providers, emergency department and regular clinic use by healthcare providers, at-home use by consumers and working with global aid and humanitarian organisations to deliver tools for the developing world.
For more information on ResApp, visit www.resapphealth.com.au.