Glycopyrronium Bromide Research Study
Research type
Research Study
Full title
A study 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
IRAS ID
294211
Contact name
Sandeep Dhanda
Contact email
Sponsor organisation
Drug Safety Research Unit
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study investigates the use and safety of Glycopyrronium Bromide 1mg/5ml oral solution for symptomatic treatment of drooling in patients < 18 years in the UK.
Eligible patients will be identified by secondary care specialist healthcare professionals (HCPs) (e.g., paediatricians) recruited to the study. Patients who have recently been started on Glycopyrronium Bromide 1mg/5ml will be invited to take part by the HCP. The decision to start Glycopyrronium Bromide will have already been made by the HCP before recruiting the patient; all this study will do is collect information about how it was prescribed and how the patient has been whilst receiving the medicine. As this is a post-marketing observational study, not a clinical trial, the patient will not be given any experimental treatment or medication as part of this study or have any additional clinical assessments; their clinical care will be unaffected.
Participation is voluntary and the patient can continue to take Glycopyrronium Bromide whatever they decide. If they agree to take part, informed consent will be obtained.The study will collect information for up to 12 months about the patient’s health and how they have been whilst taking Glycopyrronium Bromide by asking the HCP to complete electronic data collection forms (DCFs) using information already recorded as part of routine care in the patient’s medical notes. The patient’s GP will also be invited to complete a DCF at 12 months if consent has been provided.
The patient or their parent/guardian or relative/friend/person who cares for them (i.e. consultee) can also answer questions about how the patient has been whilst taking Glycopyrronium Bromide. They do not have to do this, and they can leave it to the HCP and GP to provide information. The patient’s dentist may also be contacted for information on any dental side effects.A minimum sample size of 100 patients is desirable.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0079
Date of REC Opinion
22 Mar 2021
REC opinion
Favourable Opinion