The prospective double blind study is aimed at evaluating the efficacy of the ResAppDx app in diagnosing childhood respiratory diseases from cough sounds.
Planning to enrol up to 1,667 patients
Three hospital sites in the U.S. have now received IRB approval for the study – Massachusetts General Hospital, Texas Children’s Hospital and Cleveland Clinic Children’s.
The SMARTCOUGH-C-2 study plans to enrol up to 1,667 patients aged 29 days to 12 years of age who present to one of the three participating sites in the U.S. with signs or symptoms of respiratory disease.
ResApp’s co-primary endpoints from the study are positive and negative percent agreement with clinical diagnosis for various respiratory diseases.
These include pneumonia, lower respiratory tract disease, viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease and croup.
The clinical diagnosis will be made by an independent, centralised clinical adjudication committee using all available clinical data, including radiology and microbiology.
Importantly, this represents another step towards the commercialisation of ResAppDx in the U.S.
The refined study includes major improvements over previous studies in the U.S., which is expected to deliver results that are more representative of ResAppDx’s performance.