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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Angela
Simpson
angela.simpson@manchester.ac.uk
Karen
Rhodes
Karen.rhodes@mft.nhs.uk
Other and unspecified effects of external causes
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Dietary;
You can take part if:
You may not be able to take part if:
Any of the below excludes someone from participating: 1. Females must be non-pregnant with no intention of becoming pregnant during the study. Women of childbearing potential (< 1 year post-menopausal) must agree to use (or are already on) one of the following acceptable birth control methods whilst they are enrolled in the trial: -True complete abstinence when this is in line with the preferred and usual lifestyle of the participant; -surgical sterilisation of either the female participant in the study or of her male partner, if he is the sole partner of the participant; -established hormonal contraception (implantable, patch, oral or intramuscular [IM]) administered for at least one month prior to study medication administration; -intrauterine device (IUD) or intrauterine system (IUS) with a failure rate of less than 1% per year inserted by a qualified physician, at least one month prior to study medication administration; -double barrier method: condom and occlusive cap (diaphragm) with spermicidal foam/gel/film/cream/suppository 2. Serum pregnancy test will be conducted at screening, and urine pregnancy tests (sticks) will be conducted at all other visits apart from the two follow-up visits. In the event of a positive test, the participant will be withdrawn from the trial and the pregnancy will be reported to the Sponsor. 3. Females must be non-lactating. Reports indicate that allopurinol and oxypurinol are excreted in human breast milk. Concentrations of 1.4 mg/litre allopurinol and 53.7 mg/litre oxypurinol have been demonstrated in breast milk from a woman taking allopurinol 300 mg/day. There is no data regarding the effects of allopurinol or its metabolites on the breastfed baby. 4. The participants should not be on medication that is contraindicated for the IMP or for the procedures of the trial: These are: -(due to interactions with allopurinol): Salicylates (e.g Aspirin), Uricosuric agents (e.g. febuxostat, probenecid), Phenytoin, Theophylline, Ampicillin, amoxicillin (e.g co-amoxiclav), Coumarin Anticoagulants (e.g. warfarin), Immunosuppressant and immunomodulatory drugs (e.g 6-mercaptopurine, azathioprine, cyclophosphamide, cyclosporin), doxorubicin, bleomycin, procarbazine, mechlorethamine, Antiretroviral drugs (e.g Didanosine), diuretics, Chlorpropamide, Captopril, Vidarabine (adenine arabinoside), ACE inhibitors. -(due to interference with the study design): Beta-blocking agents, ACE inhibitors, Oral or other systemic corticosteroids, anti-IgE (omalizumab), SSRI antidepressant medication. Also, the participant should not be on allopurinol. 5. Participants should not have participated in other clinical trials involving the use of an Investigational Medicinal Product (IMP) within the past 3 months. 6. There should be no previous history of a severe allergic reaction to peanut with confirmed lower respiratory symptoms or documented hypotension. 7. FEV1 should be no less than 70% predicted for age, gender and height 8. Participants should not be unable or unlikely to follow the trials procedures due to any issue (including communication issues such as language barrier). 9. The participant should not have: -Uncontrolled asthma, as defined by an Asthma Control Test (ACT) of less than 20 score, unless the failure to reach this threshold is due to consistent scheduled use of short-acting bronchodilators. -Active chronic urticaria and angioedema -Uncontrolled atopic dermatitis as defined by an ‘Objective SCORAD’ score of over 40. -Mastocytosis -Any medical condition that by study doctors judgement would compromise their safety or the reliability of the findings (including but not restricted to mast cell disorders, immune system disorders, malignancies current or past, and others) -BMI > 30 -Any contraindication to the administration of adrenaline (e.g ischaemic heart disease, poorly controlled hypertension or cardiac arrhythmia) -History of, or evidence of current use of drugs of abuse. -Allergy to any excipient of the IMP (These are: Lactose Monohydrate, Colloidal Anhydrous Silica, Maize Starch, Powdered cellulose, Sodium Starch Glycolate (Type A), Sodium Lauryl Sulphate, Povidone (E1201), Magnesium Stearate (E572) -Food Allergy to the other ingredients (apart from peanut) of the food matrix used for the challenge meal -Lactose intolerance -Galactose intolerance -Glucose-galactose malabsorption -Lapp lactase deficiency -Malignant disease -Myeloproliferative disease -Lesch-Nyhan syndrome -Abnormal liver function tests (any of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, gamma-glutamyl transferase, > 1.5 x upper limit of normal or < 0.5 lower limits of normal (if applicable); Abnormal renal function (any of urea, creatinine, blood urea nitrogen, uric acid > 1.5 upper limit of normal or < 0.5 lower limit of normal (if applicable); and/or eGFR < 60 ml/min
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST and funded by J P MOULTON CHARITABLE FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 36219
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