Assessing the utilisation and safety of Glycopyrronium Bromide for treatment of severe drooling in children.
Do you have a patient who has been prescribed Glycopyrronium Bromide 1mg/5ml oral solution?
Please consider signing up to this study, requested by the Medicines and Healthcare products Regulatory Agency (MHRA), which aims to assess the utilisation and safety of this medicine when used to treat severe drooling.
Further information about this study
Glycopyrronium Bromide has been carefully tested and has been shown to be safe and effective, but like with all medicines, it is important to continue to monitor them.
The aim of this study is to find out more information about how Glycopyrronium Bromide 1mg/5ml oral solution is being used in patients aged < 18 years in the UK and whether patients experience any symptoms/conditions after taking this medicine. Patients aged < 18 years who have been started on this medicine in secondary care (e.g., by their paediatrician) for drooling will be invited to take part.
As this is a post-marketing observational study (not a clinical trial), information will only be collected after the patient has started the medication as per routine clinical practice.
We will collect information by asking the specialist healthcare professional (HCP) to complete data collection forms (DCFs) using information from the patient’s medical notes, that has been recorded as part of the patient’s routine care. The patient’s GP will also be invited to complete DCFs if the patient agreed. The patient or their parent/guardian or relative/ friend/ person who cares for them (i.e., consultee) can also answer questions too if they would like to. They don’t have to do this, and they can leave it to the HCP/GP to provide information.
Please note that the patient does not have to participate in the study. It is their choice and they can still continue to take the medicine as normal whatever they decide. The study will recruit at least 100 patients across the UK.
If you have prescribed or plan to prescribe Glycopyrronium Bromide 1mg/5ml oral solution we would be very grateful for your help with the study.