Clin-E-Cal LTD. Public Funding

People with respiratory diseases, including asthma and COPD are usually treated with inhaler medication. This medication is designed for two purposes - preventing the disease symptoms day to day and treating incidences of worsening symptoms known as exacerbations. If a patient fails to take the preventer inhaler regularly or it is taken incorrectly, this can lead to an increase in exacerbations. As well as being a potentially life threatening situation - this can be a significant burden on healthcare services, quality of life and the economy as a whole. The project we are proposing addresses the widely recognised problems of poor inhaler technique and medication adherence. Respiratory disease is common and it is believed that more than 5 million patients in the UK are affected by issues of sub-optimal inhaler use. The problem is compounded by the multiplicity and complexity of inhaler devices. Often patients prescribed multiple different types of inhaler and inhaler education is delivered in a non-systematic way at periodic review. The economic and social burden caused by poor inhaler technique affects the young and the old. The proposed project involves developing a system that is low-cost and effective. It can be applied to existing inhaler medications to provide continuous on-device coaching and smartphone app feedback. The development project is based on significant proof of principle work already undertaken in the UK that establish; 1. A simple, low cost, on-inhaler addition can generate an acoustic guidance signal, 2. The add on device can be designed to avoid impacting medication delivery characteristics of the inhaler device, 3. Patients may receive guidance on every use - reinforcing learning, 4. Detection of their use through a smartphone App and visual representation of their technique and adherence to the treatment as prescribed, 5. Visual feedback of the App can provide learning which may consolidate the patient's practice, 6. Information may then be shared with their carer/physician to further optimise their treatment. Good inhaler technique and good adherence with a treatment regime are the cornerstones of good respiratory disease control. In turn, this imposes a lower economic burden on society and enables patients to live a better quality of life. This development can put UK innovation and manufacturing at the forefront of solving one of the major global problems associated with respiratory care.

Awaiting Public Project Summary

Viral induced wheeze or chronic wheeze associated with asthma affects 5.5 million children under 5 in Europe and the US. Our company, Clin-e-cal Ltd, has developed Rafi-tone, an innovative device which has been created to aid compliance of young children to inhaler medication delivered via a spacer device. Rafi-tone addresses two problems: in the short term, the anxiety associated with the delivery of this medication; and in the longer term maintenance of correct inhaler technique. Initially developed with a partnership between the University of Manchester and the Central Manchester Foundation Trust (CMFT), we now wish to evaluate the commercial viability of our novel product. When a child develops a wheeze, delivery of inhaled medication can be a significant challenge and can lead to substantial distress to the child and their parents. Screaming and struggling can exacerbate the wheeze and reduce the amount of drug delivered to the child. Clin-e-cal Ltd has developed an innovative solution which operates a simple and fun to use educational device when the spacer is used correctly. The device is engaging, simple and intuitive to operate for children as young as 18 months which will drive adoption. As the child continues to use the spacer, the concern shifts from the acute problem to an ongoing concern that the inhaler medication is actually being delivered in an effective dose and the correct inhaler technique is maintained. Solutions which have previously been developed to address this need have focused on novel spacer designs, rather than creating an accessory to the patient’s existing spacer. Our technology can be used with all of the most commonly used spacer devices and therefore will be accessible to over 97% of current users of spacers. Our research to date leads us to believe that Rafi-tone will be welcomed by parents and healthcare professionals, reducing a significant source of stress during what is already a highly demanding situation.