What part of the second last line don't people get.?????
ASX / MEDIA RELEASE
ResApp Extends SMARTCOUGH-C Study
Brisbane, Australia, 19 April 2017 -- ResApp Health Limited (ASX:RAP), a leading
digital health company developing smartphone applications for the diagnosis and
management of respiratory disease, today announced that it will extend the
SMARTCOUGH-C study through to the
end of May and increase maximum
recruitment to 1,500 patients. Enrolment in the study has progressed well across
eleven recruitment locations maintained by the three participating 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 enrolment, release topline
results and submit its de novo submission to the FDA in the first half of CY2017.
About the SMARTCOUGH-C Study
SMARTCOUGH-C is a multi-site, double blind, prospective clinical study to investigate
ResAppDx for the diagnosis of respiratory disease in infants and children using
cough sounds.
The study aims to enroll up to 1,500 patients aged 29 days to 12
years. The co-primary endpoints of the study are the diagnosis of pneumonia
compared to clinical and radiologic diagnosis. Secondary endpoints are diagnosis of
upper respiratory tract infection, lower respiratory involvement, croup,
asthma/reactive airways disease and bronchiolitis compared with a clinical
diagnosis.
A range of smartphone models are used. Details of the study can be
found at
www.clinicaltrials.gov (NCT02973282).
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