A number of clinical studies have been performed to develop the current prototype device and integrated sensor
Redecol will be attending EAACI in 2019 for the second year running to present the final date from our Indian study demonstrating equivalence to Spirometry in detecting changes in lung function.
2017 Clinical Programme
Redecol completed 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 vs spirometry of 20 participants conducted by Professor Wardlaw. The primary objective was optimising the performance of the device and demonstration that the device detected changes in lung function. This objective was achieved and a paper presented at EAACI in May 2018
A multicentre study conducted in India with 100 participants has been completed and the interim data has been presented at BTS in December 2018. This comparator study followed each participant for four weeks with the AMD vs spirometry. This was published in the BTS supplement of Thorax Dec 2018.
2019 and Beyond
EAACI 2019 will see the final data presented from the 100 patient study conducted in India in 2018, this demonstrates equivalence with Spirometry in detecting changes in lung function.
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.