Status:
COMPLETED
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
Lead Sponsor:
Imperial College London
Conditions:
Anaphylaxis
Eligibility:
All Genders
13-18 years
Phase:
PHASE4
Brief Summary
Food allergy affects up to 2% of adults and 8% of children in the United Kingdom (UK), and is a major public health issue. It is the commonest cause of life-threatening allergic reactions (anaphylaxis...
Eligibility Criteria
Inclusion
- Age 13 - 18 years inclusive
- Body mass \>40kg
- Prescription of AAI due to physician diagnosis of Immunoglobulin E-mediated food allergy.
- Written informed consent from parent/guardian together with patient assent, for participants under 16 years of age. For young people age 16+ years, consent will be obtained from the participant themselves.
Exclusion
- Known cardiac comorbidity (including hypertension, structural or electrophysiological diagnoses) or prescribed a medicine to control cardiovascular disease/hypertension.
- Known endocrine or renal disease
- Poorly controlled asthma requiring daily rescue treatment with a bronchodilator.
- Pregnancy
- Unwilling or unable to comply with study requirements
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03366298
Start Date
November 24 2017
End Date
October 2 2018
Last Update
September 7 2022
Active Locations (1)
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1
Imperial College London / Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY