Analysing the use of glycopyrronium bromide for excessive drooling in young children
| ISRCTN | ISRCTN17293938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17293938 |
| IRAS number | 325926 |
| Secondary identifying numbers | PRO/GLY/005, CPMS 55572 |
- Submission date
- 16/10/2024
- Registration date
- 24/10/2024
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
This study reviews the use of glycopyrronium bromide for the treatment of severe drooling in children below 3 years of age. The purpose of the study is to gather information on its effects and side effects when used in this age group. This information will be obtained from the medical notes of patients already treated with glycopyrronium bromide.
Who can participate?
Children below 3 years of age treated with glycopyrronium bromide who have medical notes at each of the participating sites
What does the study involve?
No participant/patient involvement is required for this study. Researchers will review the medical notes and extract the information required to answer the study questions.
What are the possible benefits and risks of participating?
There will be no direct benefit to those participants who have contributed to the study. The study may benefit children in the future by gathering more efficacy and safety data on the use of glycopyrronium bromide in children under 3 years of age.
As this is a study looking through medical notes only, risks are not anticipated for participants in the study.
Where is the study run from?
The study will be open at five sites throughout the UK - Alder Hey Children’s NHS Foundation Trust, Gateshead Health NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Solent NHS Trust and Great Ormond Street Hospital for Children NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
August 2022 to July 2024
Who is funding the study?
Proveca Ltd
Who is the main contact?
Dr Louise Bracken (Chief Investigator) - Lousie.Bracken@alderhey.nhs.uk
Contact information
Principal Investigator
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
 ORCID ID |
0000-0002-9632-2252 |
|---|---|
| Phone | +44 (0)1512525570 |
| louise.bracken@alderhey.nhs.uk |
Public, Scientific
Proveca Ltd
WeWork
One St Peter's Square
Manchester
M2 3DE
United Kingdom
| Phone | +44 (0)1614682627 |
|---|---|
| jamesmoss@proveca.com |
Study information
| Study design | Multicentre observational retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Medical and other records |
| Study type | Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Retrospective analysis of real-world evidence on the use of glycopyrronium bromide in children under 3 years of age with sialorrhea |
| Study objectives | This study is intended to collect retrospective real-world data on the use of glycopyrronium bromide in children under 3 years old, which is not covered by the current license. It is hoped that the data will allow for a retrospective analysis of the safety and efficacy of glycopyrronium bromide in this age group. |
| Ethics approval(s) |
Approved 19/05/2023, London - Hampstead Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 (0)207 104 8009; hampstead.rec@hra.nhs.uk), ref: 23/LO/0427 |
| Health condition(s) or problem(s) studied | Sialorrhoea |
| Intervention | This is an observational, retrospective, cohort study of enteral glycopyrronium bromide administered for the symptomatic treatment of severe sialorrhoea in patients below 3 years of age, using information already recorded in medical records. Participants who meet the study eligibility criteria will be eligible for inclusion into the study. The study procedures will be limited to the review of the existing medical records of participants from birth to 3 years of age treated with glycopyrronium bromide for sialorrhoea. Potential participants will be identified through a review of the available medical records at participating sites. The national data opt-out will be checked by sites, to ensure no data collected is not from participants who have ‘opted out’. An assessment of compliance with the inclusion/exclusion criteria will be made following subject identification. If all the inclusion criteria are met and the participant lacks all the exclusion criteria, data from the participant will be considered for this retrospective study. If the inclusion criteria are not met, data from the participant will not be collected. Participant data will be extracted from patient’s medical records at each study site and entered into a secure, access-controlled eCRF (REDcap database). |
| Intervention type | Other |
| Primary outcome measure | There is no primary outcome measure. The study was not powered for a primary outcome measure - all outcome measures are described in the secondary outcomes |
| Secondary outcome measures | The following secondary outcome measures will be assessed using data collected in the REDcap database at one timepoint: 1. Number of participants with adverse events, where causality has been attributed to glycopyrronium bromide 2. Number of participants with serious adverse events, where causality has been attributed to glycopyrronium bromide 3. Number of participants with glycopyrronium bromide dose reductions due to adverse events 4. Number of participants with glycopyrronium bromide discontinuation due to adverse events 5. A change in a drooling severity scale such as the Drooling Impact Scale (DIS), Modified Teacher's Drooling Scale (mTDS) or other relevant scales. In the absence of any formal rating scale or any other terminology/description/indication that there has been no change, an improvement, or worsening of drooling or sialorrhoea symptoms will be reviewed. 6. Number of participants where glycopyrronium bromide is discontinued due to treatment failure |
| Overall study start date | 25/08/2022 |
| Completion date | 19/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Days |
| Upper age limit | 30 Months |
| Sex | Both |
| Target number of participants | 50-100 |
| Total final enrolment | 53 |
| Key inclusion criteria | 1. Aged from birth to less than 30 months of age at the time that glycopyrronium bromide was commenced 2. Treated with glycopyrronium bromide for sialorrhoea (or equivalent terminology) via the enteral route |
| Key exclusion criteria | 1. Treatment with glycopyrronium bromide for other reasons than sialorrhoea 2. Aged 30 months or over at the time that glycopyrronium bromide was commenced 3. Glycopyrronium bromide given by a route other than the enteral route |
| Date of first enrolment | 25/08/2023 |
| Date of final enrolment | 19/03/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Eaton Road
West Derby
Liverpool
L12 2AP
United Kingdom
Durham Road
Low Fell
Gateshead
NE9 5AR
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Great Ormond Street
London
WC1N 3JH
United Kingdom
Sponsor information
Hospital/treatment centre
Alder Hey Children’s NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
England
United Kingdom
| Phone | +44 (0)1512525570 |
|---|---|
| research@alderhey.nhs.uk | |
| Website | https://www.alderhey.nhs.uk/ |
"ROR" |
https://ror.org/04z61sd03 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the full datasets being commercially sensitive and potentially used to support marketing authorisation applications |
Editorial Notes
06/11/2024: Internal review.
21/10/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
