The University of Manchester (UoM) has been awarded Wellcome Trust (WT) funding to undertake a pilot scheme that will build...Read more
Cough Monitor innovation generates income for NHS Trust
Chronic coughing (a cough lasting more than 8 weeks) is an unpleasant and distressing condition which can severely impact on a patients’ quality of life. Coughing is the most common symptom for patients seeking medical advice, with chronic cough affecting approximately 12% of the UK population.
The treatment of cough is an unmet clinical need. In 2017, £430 million was spent on over the counter cough and cold medicines, but there is limited evidence of the effectiveness of these treatments for cough and some concerns about the safety of their use, especially in children. No treatments are licensed in the UK for the treatment of chronic cough and in the US the last new cough treatment was licensed in 2953.
It is not something that should be ignored either, as coughing can have a significant impact on quality of life, including: lack of sleep, depression, lost work and syncope (fainting). Severe coughing, which is a symptom of conditions such as asthma, chronic obstructive pulmonary disease (COPD) or gastroesophageal reflux disease (GERD), can mean a patient coughs hundreds and even up to thousands of times per day.
The mechanisms and causes of cough are still poorly understood, with further research required into the characteristics and nature differences in cough. Furthermore, the development of new treatments for cough has arguably been limited by the lack of validated measures. With this in mind, researchers at Manchester University NHS Foundation Trust (MFT) and University of Manchester (UoM) have been at the forefront of this research, identifying the need for a means to objectively monitor coughing, which can lead to the collaboration with the company Vitalograph Ltd.
Prior to the development of the VitaloJAK™ Cough Monitor system and signal processing algorithm there was no accurate method for objectively measuring cough available, despite various attempts to develop a cough monitoring device or cost-effective method of analysis during the last 40 years.
Availability of the VitaloJAK system provides an objective and fully validated measure of cough, which is improving our understanding of the mechanisms driving cough in lung diseases and has also changed the standards by which cough treatments are evaluated. Cough monitoring is now a requirement of regulators for new drug applications where efficacy in treating cough is listed.
Developed by Kevin McGuinness (Clinical Engineer), Professor Jaclyn Smith (MCR Clinician Scientist/Honorary Consultant/Improving Respiratory Symptoms Programme Lead for Manchester Biomedical Research Centre) and Professor Ashley Woodcock (Professor of Respiratory Medicine) at MFT and Vitalograph Ltd, a world-leading manufacturer of respiratory diagnostic products, the cough monitor is a portable device for the quantification of coughing from sound recordings. Patients are set up with the device by a member of the clinical/research team and return 24 hours later having been able to continue with their normal activities. On their return, the data is downloaded and custom software removes non-cough sounds and silences to allow cost-efficient identification of the number of coughs during the period of use by trained audio-analysts.
The device won the first prize in the medical device category of TRUSTECH’s 2008 North West NHS Innovation Awards and has since been used in clinical studies on novel therapeutics for cough. Initially these were single centre, early phase studies conducted by Professor Jaclyn Smith and her research team, but since 2015 these have been larger phase multi-centre studies.
The development of the Vitalograph web portal, Cough Analyst training procedures and the implementation of stringent quality requirements has resulted in a cough analysis process independently verified to offer exceptional accuracy and repeatability in excess of 99.9% correlation. These studies also gave detailed information on the requirements for the device, leading to an updated design with many usability improvements.
In total, there are now over 21 Phase II or later studies completed or underway, requiring analysis of over 21,000 recordings (over half a million hours in duration) with many further trials in prospect as pharma companies respond to the previously unmet challenge of treating cough.
How TRUSTECH helped
TRUSTECH was approached to work with the researchers once the initial validation of the device had been carried out and the researchers were beginning discussions with the commercial partner. TRUSTECH organised for assignment agreements to be put in place to ensure the Trust owned all the Intellectual Property (IP) associated with the device (as the researchers work for more than one employer). TRUSTECH then helped the Trust to file a new patent on the device and negotiated a licence agreement with Vitalograph Ltd to allow the collaboration to begin. The initial agreement for the collaboration was subsequently found to be inconsistent with the project, with TRUSTECH enlisted to resolve the issues. TRUSTECH were key in identifying the final form of the IP and commercially acceptable licence terms allowing a harmonious agreement being finalised. Following the successful commercialisation of the VitaloJAK system the first royalty payments are due to be paid to the Trust in June 2018. The researchers are continuing to work with Vitalograph Ltd to further develop the system as part of a commercial service for use in clinical trials and to facilitate further academic research into cough.
Are you interested in sponsoring a cough related clinical trial?
The VitaloJAK is used within Manchester Clinical Research Facility for single centre cough studies and medicine evaluations. Please contact TRUSTECH at firstname.lastname@example.org to have your enquiry forwarded to the appropriate researcher.
For multi-centre clinical trials, please contact Vitalograph Ltd directly: they have resources and experience to conduct multi-centre and global respiratory clinical trials including, in the future, cough studies. Contact: email@example.com.
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