Brisbane, Australia, 13 December 2017 — 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 has received institutional review board approval at Baylor College of Medicine and Texas Children’s Hospital for the SMARTCOUGH-C-2 study. Texas Children’s Hospital is one of three US hospital sites that will participate in the study.
SMARTCOUGH-C-2 is a prospective, multi-site, double blind study that will evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood respiratory diseases from cough sounds.
The SMARTCOUGH-C-2 study will enrol patients aged 29 days to 12 years of age who present to a participating site with signs or symptoms of respiratory disease. The co-primary endpoints for the study are positive and negative percent agreement with clinical diagnosis for pneumonia, lower respiratory tract disease, viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease and croup. The clinical diagnosis will be made by an independent, centralised clinical adjudication committee using all available clinical data, including radiology and microbiology.
SMARTCOUGH-C-2 is a follow-on from ResApp’s SMARTCOUGH-C study, which was not a representative evaluation of ResAppDx due to a range of issues during execution and clinical adjudication. SMARTCOUGH-C-2 is a refined study with an array of enhanced procedures and features developed in collaboration with the participating hospitals.
“There were significant learnings from our previous SMARTCOUGH-C study and we are pleased with the improvements that we, alongside our clinical advisory board and the principal investigators at the study sites, have made,” said Tony Keating, CEO and Managing Director of ResApp Health. “We now look forward to recruiting patients over the US winter and obtaining results that are a true representation of our technology’s performance.”
The principal investigator at Baylor College of Medicine and Texas Children’s will be Dr. Esther Maria Sampayo, Assistant Professor of Pediatric Emergency Medicine at Baylor College of Medicine.
The details of the study will soon be published on the US National Institutes of Health clinical trials database at www.clinicaltrials.gov.
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 cough sounds 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 adult and paediatric clinical studies underway at leading US and Australian hospitals with results demonstrating accurate diagnosis of pneumonia, asthma/reactive airways disease, bronchiolitis, croup, chronic obstructive pulmonary disease and upper respiratory tract infections. Potential customers of ResApp’s products include healthcare providers in telehealth, emergency department, urgent care and primary care settings as well as humanitarian organisations in the developing world.
In the United States, ResAppDx is an investigational device and is not available for sale.
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
© 2020 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. ResAppDx is not available for sale in the United States.