ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, today announced that the initial phase of its SMARTCOUGH-C study is nearing completion. As of 25 May, 1,157 patients have been enrolled across the three participating hospitals and ResApp is pleased to report that it has reached its target recruitment numbers for all study endpoints, including those for pneumonia, upper respiratory tract infection, lower respiratory tract involvement, croup, asthma/reactive airways disease and bronchiolitis. Principal investigators at the hospital sites and the managing CRO, INC Research now require two weeks (until the week ending 16 June) to close out recruitment before final data verification begins.
“Recruiting 1,157 paediatric patients in less than five months is a significant achievement and we are pleased to have reached the target enrolment numbers for all of our planned endpoints, which span a broad spectrum of childhood respiratory disease,” said Tony Keating, CEO and Managing Director of ResApp Health.
Following this initial phase, clinical and radiologic adjudication will be conducted for the remaining patients and final source data verification site visits will be performed by INC Research. The analysis team will then prepare the top-line results, which are expected in July, while in parallel ResApp and its FDA consultants will finalise the de novo submission for ResAppDx.
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.
ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000
© 2019 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries.