ResApp Health (ASX: RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, announced that it has completed enrolment in its SMARTCOUGH-C study which investigates the diagnosis of respiratory disease in infants and children using cough sounds.
A total of 1,245 patients have been enrolled across the three participating hospitals, all located in the United States.
ResApp has reported that it has exceeded its target recruitment numbers for all study endpoints, including those for pneumonia, upper respiratory tract infection, lower respiratory tract involvement, croup, asthma/reactive airways disease and bronchiolitis.
CEO and Managing Director of ResApp Health, Tony Keating stated:
“We are grateful to all of the patients for their willingness to participate in the study, as well as the investigators and their teams for their hard work and considerable skill that has made this study possible.”
“We are excited to reach this important milestone, which brings us closer to our goal of providing a rapid and accurate diagnostic tool to aid clinicians in making better informed treatment decisions.”
With enrolment complete, the study now enters the data verification phase, where clinical and radiologic adjudication will be conducted for the remaining patients and final source data verification site visits will be performed.
Following data verification the analysis team will prepare top-line results, which are expected in July.
About the SMARTCOUGH-C Study
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 enrol up to 1,500 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. A range of smartphone models are used.
Details of the study can be found at the government clinical trials website.
In the United States, ResAppDx is an investigational device and is not available for sale.
About ResApp Health
ResApp Health 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.