ResApp Health announced the launch of its SMARTCOUGH-C clinical study in the United States, evaluating the efficacy of ResAppDx, a mobile application designed to aid in the diagnosis of childhood pneumonia and other respiratory conditions.
SMARTCOUGH-C (NCT02973282) is a large, prospective, double-blind study aiming to recruit up to 1,111 infants and children, 29 weeks to 12 years old. Co-primary efficacy endpoints include the app’s efficacy at diagnosing pneumonia versus cases detected through radiologic and clinical methods (via positive and negative percent agreement). Secondary endpoints are the diagnosis of other common childhood respiratory diseases (like upper respiratory tract infection or asthma) compared with a clinical diagnosis.
The study is being conducted at hospitals in Massachusetts, Ohio and Texas; more information about the trial and its enrollment is available on its clinical trials.gov webpage.
“In recent months we have devoted key resources to our pivotal US paediatric clinical study to ensure that it commenced during the onset of winter and we are very pleased to announce that our first patients have been enrolled on schedule,” Tony Keating, chief executive officer and managing director of ResApp Health, said in a press release. “Starting this study is a major milestone for the company as we rapidly bring ResAppDx to market. The results gathered will underpin our planned de novo premarket submission to the FDA.”
The clinical trial builds on ResApp’s Australian pediatric clinical study, which demonstrated accurate diagnoses of pneumonia, asthma, bronchiolitis and upper respiratory tract infections, among others. This trial is a collaborative project between Joondalup Health Campus (JHC) and the Wesley Hospital in Australia, and preliminary results were analyzed by a research team from the University of Queensland.
ResApp Health is developing smartphone applications, based on machine learning algorithms that use sound to detect and measure the severity of respiratory conditions without the need for additional hardware. The company has both adult and pediatric clinical studies underway, with preliminary results showing accurate diagnoses in both patient groups, mostly for chronic obstructive pulmonary disease (COPD), asthma, and pneumonia.
Pneumonia is the leading cause of death in children under five years of age worldwide, and is the most common reason for children to be hospitalized in the United States. Today, diagnoses of respiratory diseases are based on combinations of auscultation, imaging and lab tests.