Study to investigate the drug treatment for sialorrhoea in children over the past 10 years.

Date of ISAC Approval: 
18/09/2015
Lay Summary: 
The drug manufacturer has been asked to provide detailed information on the prescribing of glycopyrronium bromide (GB) as part of a European-wide licensing application for its liquid GB for the treatment of a condition referred to as chronic pathological drooling (CPD) in children with neurological disabilities. The study will use information from the Clinical Research Practice Database (CPRD) to determine how CPD has been treated in the UK for at least the past 10 years. The researchers will review the records of children treated for CPD to determine which drugs they have been prescribed and the time over which they have been treated. Since CPD may not always be captured as a specific presciption reason, researchers will also review records for all children treated with GB via the oral route to determine when each prescription formulation should be used and at what dose. In addition, the records will be reviewed for GB use via intramuscular and intravenous routes, since CPD is known to be an indication via these routes. The information will be used to address the specific licence application questions and a scientific publication will be written describing the treatment of CPD in UK. The information available in the CPRD will help to bring a much needed, licensed medical treatment to children affected by this condition.
Technical Summary: 
The proposed research aims to analyse the use of glycopyrronium bromide (GB) in paediatric prescribing for sialorrhoea (CPD) in children below the age of 18 years in the UK. This data will be presented as summary statistics to both establish the general prescribing pattern for sialorrhoea and the use pattern of (GB). The overlap of the dataset will allow the sponsor to determine the pattern of prescribing of GB for sialorrhoea in the community. This will in turn be used to estimate UK wide use of GB in the community setting as related to the information available in the Prescription Cost Analysis (PCA) database. The data will be presented to the European Medicines Agency (EMA) to provide support for the well-established use, over 10 years, of GB for the treatment of CPD in the UK.
Health Outcomes to be Measured: 
All subjects under the age of 18 years treated for sialorrhoea will have the following information recorded: age at time of each prescription; gender; drug including dose, route of administration and formulation (where available). All subjects under the age of 18 years treated with oral or single active IM or IV (since this route is also known to be used for sialorrhoea) GB will have the following information recorded: age at time of each prescription; gender; dose; route of administration; formulation (where available) and indication.
Collaborators: 

Simon Bryson - Chief Investigator - Proveca Ltd.
Helen Shaw - Collaborator - Proveca Ltd.
Helen Shaw - Corresponding Applicant - Proveca Ltd.