Tumour necrosis factor alpha antagonists and olfaction
Research type
Research Study
Full title
Investigating the effect of tumour necrosis alpha antagonists on olfaction
IRAS ID
246758
Contact name
Carl Philpott
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This study will investigate the effect of a group of medications known as Tumour Necrosis (TNF) Alpha antagonists on smell function. Deficits in smell can impact on an individauls quality of life and can be life threatening when affecting the ability to recognise danger (e.g. smoke, gas, spoiled food). Two studies conducted on mice have shown benefit of TNF-alpha antagonist on smell function. No studies have investigated the benefit of TNF alpha antagonist on smell in a human model. The aim of this study therefore would be to evaluate effect of TNF-alpha antagonists on the sense of smell in a human model.
This observational study would take place in the Norfolk & Norwich University Hospital. Participants included would be those starting on a TNF-alpha antagonist for the first time in a Rheumatology Clinic. Smell function would be assessed at the time of starting the medication and again 3 months later. Sense of smell will be assessed using Sniffin' Sticks, which is a non-invasive form of testing involving patient to identify smells, to formulate a score. The two scores before and after 3 months of treatment shall be compared. Other information recorded would include demographics (age, sex) along with a simple questionnaire asking the patient to evaluate their sense of smell.
Participants shall be approached to enter the study by a clinician at the Rheumatology clinic at the Norfolk and Norwich University Hospital. The participant shall be provided with an information sheet and given sufficient time to consider participation. Patients agreeing will be assessed for eligibility and undergo a nasal examination (ensuring there is no obstructing causing olfactory loss). Patient are able to leave the study at any point without reason. The study will run until the end of July 2019 (last follow-up).REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0593
Date of REC Opinion
23 Oct 2018
REC opinion
Favourable Opinion