Intranasal Diagnostics in Food Allergy: a Feasibility Study

Study Purpose

The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Aged 6 - 17 years old - Physician-diagnosis of food allergy on the basis of: - Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR - History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR - Evidence of >95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months - Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible.

Participants aged over 16 years will need to provide their owned informed consent.

Exclusion Criteria:

- Contraindicated as acutely unwell or current unstable asthma: - Acute wheeze in last 72 hours requiring treatment - Febrile ≥38.0oC in last 72 hours - Recent admission to hospital in last 2 weeks for acute asthma - Current medication - Use of asthma reliever medication in last 72 hours - Recent administration of a medication containing antihistamine within the last 4 days - Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02159833
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Paul J Turner, FRACP PhD
Principal Investigator Affiliation	Imperial College London
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

London, United Kingdom

Status

Address

Imperial College London / Imperial College Healthcare NHS Trust

London, , W2 1NY

Clinical Trial Finder