ResApp Health Ltd will extend the SMARTCOUGH-C study through to the end of May and increase maximum recruitment to 1,500 patients. The study is a multisite, double blind, prospective clinical study to investigate ResAppDx for the diagnosis of respiratory disease in infants and children using cough sounds.
Enrollment in the study has progressed well across 11 recruitment locations maintained by the three participating US hospitals, however the incidence of pneumonia and croup among study patients has been unseasonably low. Increasing the recruitment target is a prudent step that will ensure the study generates statistically strong results and maximize the range of diseases included in ResApp’s de novo submission to the FDA.
“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.”
The company advises that it remains on-track to complete enrollment, release top-line results and submit its de novosubmission to the FDA in the first half of CY2017.