ResApp Health Ltd (ASX:RAP) has completed the enrolment for the double-blind stage of its paediatric (children) Breathe Easy study.
A total of 681 paediatric patients have been recruited at Joondalup Health Campus and Princess Margaret Hospital in Perth, Australia.
The Breathe Easy study is evaluating the efficacy of ResApp’s smartphone application for the diagnosis of childhood acute respiratory disease using cough sounds.
The study will be used to support European (CE) and Australian (TGA) regulatory submissions.
Top-line results expected this month
ResApp’s CEO and managing director Tony Keating said: “Results from the Breathe Easy study are expected this month, before SMARTCOUGH-C-2 results have been finalised.
“Upon receipt, we will move quickly forward with regulatory submissions for Europe and Australia.”
Also recently completed enrolment for SMARTCOUGH-C-2 study
Earlier this week, ResApp completed the enrolment for 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 a total of 1,470 patients at three hospital sites in the United States.
Developing smartphone apps for breathing diseases
ResApp is a digital health company developing smartphone applications for the diagnosis and management of respiratory disease.
The company’s technology uses sound to diagnose and measure the severity of respiratory conditions without the need for additional hardware.
ResApp is expecting results from three studies this quarter being the US SMARTCOUGH-C-2 clinical study, Australian Breathe Easy clinical study, and Obstructive Sleep Apnoea proof-of-concept study.