Brisbane, Australia, 9 March 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 recruitment of patients in its revised paediatric clinical study in the United States, SMARTCOUGH-C-2, is progressing well with 640 patients recruited across the three hospital sites. ResApp’s SMARTCOUGH-C-2 study is evaluating the efficacy of the ResAppDx smartphone application in the diagnosis of childhood acute respiratory disease using cough sounds.
Independent quality assurance of the cough audio recordings has been performed on-site, as per the study protocol, and a sample of the audio recordings have been reviewed directly by ResApp. Both of these reviews will continue throughout the study to ensure that audio quality is maintained.
“We are very pleased with the recruitment rate to date, which exceeds the rate we achieved this time last year, in part due to this year’s worse-than-normal flu season in the United States,” said Tony Keating, CEO and Managing Director of ResApp. “We also note that the improvements we made in training and processes are yielding high quality audio data and that our efforts to homogenise clinical adjudication practices have been well received by the participating hospitals and the independent clinical adjudication team. We look forward to obtaining solid, representative results from the study in the middle of this calendar year and rapidly progressing ResAppDx towards regulatory submission and commercialisation.”
About the SMARTCOUGH-C-2 study
SMARTCOUGH-C-2 is a multi-site, prospective, double-blind study evaluating the efficacy of the ResAppDx smartphone application in the diagnosis of childhood acute respiratory disease using cough sounds. The 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 acute 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