RUPA v1.0
Research type
Research Study
Full title
The Role of Uric Acid Metabolism in Pathogenesis of Anaphylaxis: the Effect of Allopurinol on Experimentally-induced Allergic Reaction to Peanut in Peanut Allergic Adults- a randomised, double-blind placebo-controlled, cross-over, single centre study.
IRAS ID
217378
Contact name
Angela Simpson
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Eudract number
2017-005060-18
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
Food allergy is an important cause of severe and even fatal allergic reactions (anaphylaxis), and peanut is one of the most common culprits. Management options for food allergy are limited and the current mainstay of treatment is strict avoidance of peanut. However, lifelong avoidance combined with fear of accidental exposure have a significant negative effect on the quality of life of patients and their families.
There is now animal evidence that a chemical produced in the body, uric acid, may play a role in development of allergic reactions, and its reduction may help prevent such episodes. Allopurinol is a medication used for over half a century for conditions caused by high uric acid levels in the blood (e.g gout), as it effectively reduces uric acid. We therefore opted to conduct a cross-over study where 20 peanut-allergic adults will each receive both allopurinol and placebo, and after each treatment they will undergo peanut challenges to see if their reactivity to peanut has changed
In more detail, each participant will be in the study for 21-40 weeks and will attend nine hospital visits. If participants pass the first screening visit, they will undergo a double-blind placebo-controlled peanut challenge. If they are shown to be peanut-allergic they will be randomised to two groups of ten participants each. One group will first be given 7-10 days of allopurinol, and then 7-10 days of placebo after a washout period; the other group will be given these in the opposite order (first a period of placebo and then a period of allopurinol). At the end of each treatment period, a hospital-based open challenge to peanut will be conducted to test if the participant’s reactivity to peanut has changed. Afterwards, the participants will undergo a further two hospital visits to monitor for any delayed adverse effects.Summary of Results
The trial was terminated early as a result of the COVID-19 pandemic and the primary outcome analysis has not been completed as the study was underpowered Work is ongoing towards mechanistic secondary outcomes ( as the biological samples have been adopted by a research tissue bank)REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0052
Date of REC Opinion
23 Feb 2018
REC opinion
Favourable Opinion