ResApp, an Australian company developing an app to diagnose respiratory conditions based on cough sounds, has secured the first of three IRB approvals for its upcoming Smartcough-C pediatric trial, which will take place at the Cleveland Clinic, Massachusetts General Hospital, and a third site yet to be announced.
ResApp’s offering — an app called ResAppDx — essentially uses the smartphone microphone as a stethoscope to listen to a patient’s breathing. But instead of relying solely on a doctor’s ears to form a diagnosis from those sounds, ResApp has been developing machine-learning algorithms that will automatically determine which respiratory condition a patient might have, including pneumonia, asthma, bronchiolitis and COPD. Eventually, the company hopes to integrate those algorithms into telehealth offerings as well as making them available for clinical use.
However in order to do that the company needs to secure de novo FDA clearance, and this multi-site double-blind trial will help establish some of the evidence for that clearance, the company hopes.
“We are very pleased to announce that we have received our first IRB approval for our pivotal US pediatric study,” Tony Keating, managing director and CEO of ResApp, said in a statement. “Our ultimate goal is to demonstrate the clinical accuracy of ResAppDx and improve healthcare for children everywhere.”
The company now has IRB approval for the Cleveland Clinic site. The company had previously announced Massachusetts General as another of the three sites for the trial, which will be primarily focused on diagnosing pneumonia in children. Secondary outcome measures will include diagnostic accuracy for upper respiratory tract infection, croup, bronchiolitis and asthma. Dr. John Carl MD, Director of the Center for Pediatric Pulmonary Medicine, will be the principal investigator at Cleveland Clinic.
Back in April, ResApp achieved an accuracy of 89 percent in a clinical study of 524 pediatric patients conducted by the company at Joondalup Health Campus (JHC) and Princess Margaret Hospital (PMH) in Perth, Western Australia, where the company is based. In a smaller trial of 243 adult patients, also at Joondalup, the company saw accuracy between 91 and 100 percent.