Brisbane, Australia, 11 January 2018 — ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, today announced that SMARTCOUGH-C-2, a prospective, multi-site, double blind study that will evaluate the efficacy of the ResAppDx smartphone application in the diagnosis of childhood respiratory diseases from cough sounds, has secured its third institutional review board (IRB) approval in the United States.
Three hospital sites in the United States have now received IRB approval for the study – Massachusetts General Hospital, Texas Children’s Hospital and Cleveland Clinic Children’s, which obtained approval in January 2018.
The SMARTCOUGH-C-2 study plans to enrol up to 1,667 patients aged 29 days to 12 years of age who present to one of the three participating sites in the United States with signs or symptoms of respiratory disease. The study’s co-primary endpoints 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.
More information on the study is available at www.clinicaltrials.gov (NCT03392363).
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
Headquarters: Level 8, 127 Creek St, Brisbane, QLD 4000
Registered Office: Level 24, 44 St Georges Tce, Perth, WA 6000
© 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.