ResApp Health (ASX:RAP), a digital health company developing smartphone applications for the diagnosis and management of respiratory disease, has provided an update on its SMARTCOUGH-C-2 study.
The paediatric clinical study in the US, which currently involves 640 patients across three hospital sites, plans to enrol up to 1,667 patients aged 29 days to 12 years who present with signs or symptoms of acute respiratory disease. It is evaluating the efficacy of the ResAppDx smartphone application in the diagnosis of childhood acute respiratory disease using cough sounds.
The company said independent quality assurance of the cough audio recordings has been performed on-site, as per the study protocol, and it has also directly reviewed a sample of the audio recordings.
“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 CEO and managing director Tony Keating.
“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.”