Brisbane, Australia, 27 September 2018 — ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, today provided an update on the timing of it receiving results from its SMARTCOUGH-C-2 study. The SMARTCOUGH-C-2 study is evaluating the efficacy of the ResAppDx smartphone application for the diagnosis of childhood acute respiratory disease using cough sounds and has enrolled 1,470 patients at three hospital sites in the United States.
ResApp’s contracted Clinical Research Organisation and the site Principal Investigators have notified the Company that adjudication is progressing well and that based on the projected availability of adjudicators it will be approximately two weeks before the data is un-blinded and preliminary top-line results are delivered.
“We thank the adjudicators and site staff for their commitment to the integrity of the study and for their efforts to close out the study as quickly as possible while managing their many other responsibilities,” commented Tony Keating, CEO and Managing Director. “With high quality cough sound recordings and an objective, rigorous adjudication process, our pivotal US clinical study is in great shape and we look forward to reporting results in mid October.”
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 enrolled 1,470 patients aged 29 days to 12 years of age who presented 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 airway 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 leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease. ResApp’s machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional hardware. Clinical studies are underway at leading hospitals in the United States and Australia, and previous studies have demonstrated accurate diagnosis of pneumonia, asthma/reactive airway disease, bronchiolitis, croup, chronic obstructive pulmonary disease and upper respiratory tract infections. ResApp has also obtained excellent results for screening of obstructive sleep apnoea in a proof-of-concept clinical study. 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.
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.