Utilisation and safety of Glycopyrronium Bromide (GPB) oral solution for the treatment of sialorrhoea in children <18 years in the UK

Date of ISAC Approval: 
28/04/2020
Lay Summary: 
Glycopyrronium bromide is used to help relieve the difficulties associated with drooling (sialorrhoea) in children 3 years of age or older. This study aims to investigate the use of glycopyrronium bromide oral solutions and oral tablets, in children under 18 years of age in the UK, and whether these children experience any side effects while using the medication. Findings from this study may be used to support a glycopyrronium bromide oral solution license application at a specific dose (1mg/5ml) which would be used in the treatment of drooling in children. This study will provide information on the dose and length of treatment in patients under 18 years of age using current formulations of the drug, as well as usage in different age groups under 18 years of age. It will also look at reasons for clinical consultations to examine the underlying reasons for prescribing and describe the medical history of these patients. In addition the study will examine patients under 18 years of age who have been diagnosed with drooling and examine the prescribing of glycopyrronium bromide in this group. Reasons for clinical consultations for patients diagnosed with drooling who have been prescribed the 1mg per 5ml oral solution of the drug will be used to examine whether these children experience side effects while using the medication.
Technical Summary: 
This cohort study will assess the use of oral solutions and oral tablets of GPB in children under 18 years of age and the safety profile of GPB 1mg/5ml oral solution during treatment. The study will also assess the prescribing of oral solutions and oral tablets of GPB in children under 18 years of age who have been diagnosed with sialorrhoea. All patients that have been prescribed oral solutions and oral tablets of GPB, as well as patients who have been diagnosed with sialorrhoea (irrespective of GPB prescribing) will be examined. The safety profile of GPB 1mg/5ml oral solution during treatment for patients diagnosed with sialorrhoea will be analysed. Categorical data will be presented as tabulations; continuous data will be described using appropriate summary statistics (mean/SD or median/IQR). Reasons for consultations will be tabulated using grouping based on clinical code levels to allow for patterns to be examined as individual recording variation may otherwise preclude signal detection. Incidence risks will be calculated for safety events.
Health Outcomes to be Measured: 
- Dosages and duration of GPB treatment Demographic of patients measured will include: - Age at first GPB prescription - Age at the start of each GPB treatment episode - Gender - Weight (kg) at the time of the first GPB prescription (in the 30 days prior to and including first ever GPB prescription) - Prior medical history (reasons for consultations) - Indications for prescribing GPB (reasons for consultations) - Number of GP practices - Reasons for consultations during primary care treatment to examine adverse events during treatment with GPB 1mg/5ml oral solution for patients with an indication of sialorrhoea (e.g. dry mouth, constipation, diarrhoea) - Reasons for consultations after stopping treatment with GPB 1mg/5ml oral solution for patients with an indication of sialorrhoea - Adverse events of interest will also include central nervous system effects (in particular behavioural effects), renal system effects (in particular urinary retention), respiratory effects (cough, pneumonia, respiratory infections), neurodevelopment effects, constipation and diarrhoea
Collaborators: 

Professor Saad Shakir - Chief Investigator - Drug Safety Research Unit
Dr Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Dr Sandeep Dhanda - Collaborator - Drug Safety Research Unit
Dr Vicki Osborne - Collaborator - Drug Safety Research Unit