Sial-Bot
Research type
Research Study
Full title
Exploring the clinical application of incobotulinumtoxinA for sialorrhea treatment in those with aspiration pneumonia: a pilot study
IRAS ID
333733
Contact name
Prashanth Reddy
Contact email
Sponsor organisation
King's College Hospital
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The Sial-Bot study aims to explore the use of incobotulinumtoxinA (Xeomin®), a well-established licensed treatment, for managing excessive drooling (sialorrhea) in patients. Sialorrhea is a known cause of Aspiration Pneumonia. Aspiration pneumonia occurs when saliva or food is accidentally inhaled into the lungs, leading to infection. Sialorrhea, often caused by neurological conditions like Parkinson's disease, increases the risk of this type of pneumonia.
In this pilot study, we will observe five patients who have already received the Xeomin® injection as part of their standard medical care at King’s College Hospital. The study begins after the injection has been administered, focusing on how well the treatment reduces symptoms of sialorrhea and the recurrence of aspiration pneumonia over a three-month period.
To assess the effectiveness of the treatment, we will conduct two Fibreoptic Endoscopic Evaluation of Swallowing (FEES) procedures, a routine method used by trained Speech and Language Therapists. FEES involves passing a small camera through the nose to observe the throat as the patient swallows. This procedure will help us measure changes in saliva management before and after the treatment.
The study poses minimal risk to participants, with the primary risks associated with the FEES procedure, such as minor nosebleeds or irritation, which are rare and usually resolve quickly.
By reducing sialorrhea, we hope to lower the incidence of aspiration pneumonia, which could improve patient outcomes and reduce hospital admissions. The findings from this study will inform future research and potentially support wider use of Xeomin® for sialorrhea management in similar patient groups.
This study is non-commercial, sponsored by King's College Hospital, with a grant supported by Merz Therapeutics GmbH, and will contribute valuable information to improve patient care in the NHS.
REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0287
Date of REC Opinion
5 Feb 2025
REC opinion
Further Information Favourable Opinion