Prediction and prevention of Asthma attacks in Children

Background Asthma attacks are costing lives and draining healthcare budgets. Attacks are preventable, but continue to occur with failures to identify early warning signs. Patients, carers and clinicians require reliable data to guide proactive care.

However, existing solutions (peak-flows, symptom-diaries) provide incomplete assessments and limited by technique, subjectivity and adherence.

Our monitoring device and predictive analytics addresses these needs, providing comprehensive assessments of asthma risk.

It continuously, objectively and passively monitors known markers of asthma risk (respiratory rate, nocturnal cough, wheeze) and key environmental triggers. Aims The current solution is developed for adults and CE-marked for research-use.

Thus, key aims are to: a) gather clinical data to develop the solution for specific needs of children and parents. b) develop technical back-end infrastructure for interoperability and scalability within existing NHS infrastructure. c) regulatory validation study to collect evidence on clinical efficacy, safety and usability d) enable clinical adoption (incl.

CE-marking as medical device, health-economic analysis, commercial, IP, and adoption strategy). Project plan comprises work-packages across clinical, technical, commercial, IP and regulatory aspects.

Two clinical studies are planned, first an observational data gathering study to enable development of paediatric-specific solution; second, regulatory validation via Clinical Investigation of Medical Device study. These are accompanied by technical development work-packages on the device, analytics and data system.

Finally, we will plan and implement requirements through clinical-adoption and commercial work-packages. Timelines for delivery Project is 36months in total (increased accounting for anticipated COVID-19 impact).

Preparations for Study1 (3months) Study1 (15m) Study1 analysis and Preparations for Study 2 (3m) Study2 (12m) Study2 analysis and final preparations for regulatory submission (3m) Anticipated impact and dissemination An automated monitoring and predictive solution has potential to prevent personally devastating and systemically costly asthma attacks.

The clinical findings will be disseminated through peer-reviewed publications, whilst clinical adoption will occur via AHSNs.