Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

GLYCOPYRRONIUM BROMIDE

Medical condition to be studied

Salivary hypersecretion
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)

Estimated number of subjects

100
Study design details

Main study objective

To assess utilisation and safety of Glycopyrronium Bromide 1mg/5ml Oral Solution as licensed for symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders in the UK.

Outcomes

To describe utilisation of Glycopyrronium Bromide 1mg/5ml Oral Solution in the UK in patients <18 years: 1. To describe off-label use in patients aged below 3 years and/or patients with mild to moderate sialorrhoea 2. To quantify the incidence of patients with the sialorrhoea indication that have a follow up consultation for the medication/indication in secondary and/or primary care, To examine safety in long-term use (as defined by >24 weeks ) for the sialorrhoea indication. This will include: 2.1. To examine the incidence of important identified and potential risks within the first 12 months after starting treatment for the sialorrhoea indication

Data analysis plan

Evaluable cohort demography will be presented using summary descriptive statistics including age and gender, as reported at index date using all available information from electronic data collection forms. Duration of treatment for all patients will be presented using summary descriptive statistics. Use for longer than 24 weeks will be quantified, and adverse events reported after 24 weeks will be summarised.