ASX / MEDIA RELEASE ResApp Receives Institutional Review Board...

ASX / MEDIA RELEASE
ResApp Receives Institutional Review Board Approval at Texas Children’s Hospital for SMARTCOUGH-C-2 Study
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.