The trial incorporates the use of home telemetry to measure lung and cardiovascular function, levels of physical activity and body composition, which are combined with the measurement of biomarkers to predict the reoccurrence of chest infections.
This trial explores whether CF patients could self-monitor at home, with remote support from their clinicians, using the Company’s home infection test and the Activ8rlives web-based platform.
The Company successfully bid for and was awarded Phase 1 funding through NHS Midlands and East and the Health Enterprise East's second SBRI competition in 2011. In May of last year, Aseptika was also awarded Phase 2 funding to undertake this current study.
The company has already demonstrated the feasibility of quantifying the levels of key biomarkers in sputum samples as a way of predicting the onset of chest infections known clinically as 'exacerbations'. The biomarker tests can be used to give both clinicians and patients 7 to 10 days advanced warning of an exacerbation and when commercialised, could lead to a reduction in hospital admissions and length of stay, as well as improving healthcare outcomes for those with CF.
In the trial, volunteers measure key performance indicators of health such as Peak Flow, FEV1, pO2, heart rate, physical activity, weight, body composition, cough and wellness at home and this information is uploaded to their private Activ8rlives web account. The sputum profiling data is added to this same web database and correlated with the volunteer’s medication regime. This wealth of information can be viewed by the clinician for research purposes only at this stage during the trial, but will be made available to the patients at its completion.
In a comment on the current clinical trial, Dr. Anne Blackwood, Chief Executive of Health Enterprise East said, “Aseptika's technology platform has the potential to improve the quality of life of patients with CF in addition to reducing healthcare costs by preventing unnecessary admissions. Empowering patients to self-manage their condition is a key priority for the NHS.”
The objective of the self-monitoring solution being developed by Aseptika is to provide the tools to CF patients and their carers to help them stay well. Simultaneously this also provides their clinical team with complete, reliable and up to date information, especially for patients which have long journeys to attend their specialty clinics. Early changes in levels of biomarkers and health indicators will give patients, their families and clinicians every chance to identify when a course of treatment is becoming ineffective or when a change in treatment is required, or identify if additional support at home is needed.