A number of clinical studies have been performed to develop the current prototype device and integrated sensor
Clinical data from previous studies is currently being analysed in preparation for submission for publication in appropriate clinical journals.
Redecol is in the process of planning and performing a larger study which will follow one hundred patients over a five-week period. These patients will be observed as they undergo treatment for their asthma. Over this five week period their lung function will change from that of a symptomatic asthmatic to a non-symptomatic asthmatic. This will provide a database of breath profiles which can be compared to spirometry results which are the current gold standard for measuring lung function. This database will then be used to create an algorithm which can describe a patient’s breath profile and hence their lung function in a simple number. Protocols are written and approved. The study will commence in June 2017 and will conclude by September 2017.
2017 Clinical Programme
Redecol is currently performing a UK based clinical study which uses a sensor, a basic set of electronics and simple user interface. This is a simple asthma challenge study which observes a known asthmatic as they experience a range of symptom levels of severity over a two-hour period. This will provide evidence that the breath profiles can be used to differentiate between varying levels of lung function. The results currently support this expectation.
2018 and Beyond
Redecol are in the process of designing additional clinical studies with the support of an advisory board of clinical specialists. These studies will support the commercialisation of the device.