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 for its SMARTCOUGH-C study is progressing well. The study began recruitment in December 2016, with all three US hospitals active since late January 2017. Recruitment locations now include multiple emergency departments, urgent care facilities and primary care offices at each hospital. As of the 10th of March, 478 participants have been enrolled, with 91 participants recruited in the last week.
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 1,111 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. Details of the study can be found at www.clinicaltrials.gov (NCT02973282).
“We are pleased by the recent ramp-up in enrolment with all sites coming online to coincide with the peak of a US flu season that arrived later than usual,” said Tony Keating, CEO and Managing Director of ResApp Health. “We expect high per-week enrolment numbers to continue through the balance of the US flu season and we have recently incorporated additional urgent care locations to expedite the study. Our experienced principal investigators and analysis teams, drawn from leading US hospitals and universities, are all working diligently to ensure that we obtain the most robust data for our de novo FDA submission.”
The company advises that it remains on-track to complete enrolment, release top-line results and submit its de novo submission to the FDA in the first half of CY2017.
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.