ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, today announced that it will extend the SMARTCOUGH-C study through to the end of May and increase maximum recruitment to 1,500 patients. Enrolment in the study has progressed well across eleven recruitment locations maintained by the three participating hospitals, however the incidence of pneumonia and croup among study patients has been unseasonably low. Increasing the recruitment target is a prudent step that will ensure the study generates statistically strong results and maximize the range of diseases included in ResApp’s de novo submission to the FDA.
“Seasonal variations have affected the incidence rate of key diseases observed during our SMARTCOUGH-C study and we need to adapt accordingly,” said Tony Keating, CEO and Managing Director of ResApp. “By increasing the total number of patients recruited we will improve the statistical power of our results and incorporate a wider range of respiratory diseases. This in turn will strengthen our FDA submission and support our goal of providing a complete differential diagnosis tool for respiratory disease.”
The company advises that it remains on-track to complete enrolment, release top-line results and submit its de novo submission to the FDA in the first half of CY2017.
About the SMARTCOUGH-C Study
SMARTCOUGH-C is a multi-site, double blind, prospective clinical study to investigate ResAppDx for the diagnosis of respiratory disease in infants and children using cough sounds. The study aims to enroll up to 1,500 patients aged 29 days to 12 years. The co-primary endpoints of the study are the diagnosis of pneumonia compared to clinical and radiologic diagnosis. Secondary endpoints are diagnosis of upper respiratory tract infection, lower respiratory involvement, croup, asthma/reactive airways disease and bronchiolitis compared with a clinical diagnosis. A range of smartphone models are used. Details of the study can be found at www.clinicaltrials.gov (NCT02973282).
In the United States, ResAppDx is an investigational device and is not available for sale.
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 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.