ResApp Health will extend a clinical trial evaluating its investigative software ResAppDx to 1,500 children with respiratory diseases. The trial is now expected to end in May.
The clinical SMARTCOUGH-C trial (NCT02973282) is a large, prospective, double-blind study that initially was targeted to enroll 1,111 infants and children, ages 29 weeks to 12 years old. This multi-site study is testing the effectiveness of the ResAppDx software application in diagnosing childhood pneumonia and other lung diseases based on cough sounds.
Dual goals of the study include the app’s effectiveness at diagnosing pneumonia vs. cases detected through radiologic and clinical methods. Secondary goals are the diagnosis of other common childhood respiratory diseases, such as upper respiratory tract infection or asthma, compared with a clinical diagnosis.
According to a press release from ResApp Health, the enrollment of patients in the trial is progressing well across all trial sites at three participating hospitals in Massachusetts, Ohio and Texas. However, the company says that because the incidence of pneumonia is low among study participants, increasing the number of patients will ensure the study is more likely to reach robust results.
In addition, increasing the number of participants will maximize the range of diseases included in ResApp’s upcoming de novo submission to the U.S. Food and Drug Administration (FDA), a regulatory procedure for approval of entirely new devices that have no existing classification on the market.
“Seasonal variations have affected the incidence rate of key diseases observed during our SMARTCOUGH-C study and we need to adapt accordingly,” said Tony Keating, CEO and managing director of ResApp. “By increasing the total number of patients recruited we will improve the statistical power of our results and incorporate a wider range of respiratory diseases. This in turn will strengthen our FDA submission and support our goal of providing a complete differential diagnosis tool for respiratory disease,” he said.
The company plans to have results from the study and offer its de novo submission to the FDA this year.
ResApp is a smartphone application for the diagnosis and management of respiratory disease, and is based on machine-learning algorithms that use cough sounds to detect and measure the severity of respiratory complications without additional hardware.
Initial results from studies testing the effectiveness of the app in adults demonstrate accuracy and specificity in the diagnosis of pneumonia, chronic obstructive pulmonary disease (COPD), asthma, and upper respiratory tract infection (URTI).