ResApp Health Limited (ASX: RAP), the developer of smartphone medical applications for the diagnosis and management of respiratory disease, today announced the initiation of its SMARTCOUGH-C study in the US which will evaluate the efficacy of the ResAppDx mobile software application for the diagnosis of childhood pneumonia and other respiratory conditions.
The large, prospective, double-blind, multi-site clinical study aims to recruit up to 1,111 patients between the ages of 29 days and 12 years. The co-primary efficacy endpoints of the study are the diagnosis of pneumonia compared to radiologic and clinical diagnosis. Secondary endpoints are diagnosis of other common childhood respiratory diseases such as upper respiratory tract infection, croup, bronchiolitis and asthma compared with a clinical diagnosis.
More information on the study is available at www.clinicaltrials.gov (NCT02973282).
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. 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, expand access to healthcare and reduce costs.
SMARTCOUGH-C builds on ResApp’s highly successful Australian paediatric clinical study which demonstrated accurate diagnosis of pneumonia, asthma/viral wheeze, bronchiolitis, croup and upper respiratory tract infections. Analysis of the Australian study data is progressing well and ResApp will release enhanced results early in the new year.
“In recent months we have devoted key resources to our pivotal US paediatric clinical study to ensure that it commenced during the onset of winter and we are very pleased to announce that our first patients have been enrolled on schedule,” said Tony Keating, CEO and Managing Director of ResApp Health. “Starting this study is a major milestone for the company as we rapidly bring ResAppDx to market. The results gathered will underpin our planned de novo premarket submission to the FDA.”
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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.