Anaphylaxis MedDRA version: 20.0 Level: LLT Classification code 10000664 Term: Acute anaphylaxis System Organ Class: 100000023018
Conditions
Interventions
Trade Name: EpiPen® Adrenaline (Epinephrine) Auto Injector 0.3 mg
Product Name: EpiPen® Adrenaline (Epinephrine) Auto Injector 0.3 mg
Pharmaceutical Form: Injection
INN or Proposed INN: Adrenaline (
Sponsors
Imperial College London JRC Office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 13 – 18 years inclusive 2. Body mass >40kg 3. Prescription of AAI due to physician diagnosis of IgE-mediated food allergy. 4. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Known cardiac comorbidity (including hypertension, structural or electrophysiological diagnoses) or prescribed a medicine to control cardiovascular disease/hypertension. 2. Known endocrine or renal disease 3. Poorly controlled asthma requiring daily rescue treatment with a bronchodilator. 4. Pregnancy 5. Unwilling or unable to comply with study requirements All participants must be well on the study day, with: • No fever (=38.0°C) in the preceding 48 hours • No additional ß-agonist containing medication (e.g. Salbutamol) or antihypertensive (e.g. ß-blocker) in the 72 hours prior to study visit • No intramuscular adrenaline given in the preceding week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of intramuscular self-injection of 300mcg and 500mcg adrenaline on blood levels of adrenaline ("pharmacokinetics") and the effect on the heart (blood pressure, heart rate, cardiac output), in food-allergic teenagers over 40kg, using an auto-injector device.;Secondary Objective: 1) To assess the effect of intramuscular self-injection of 300mcg adrenaline on blood levels of adrenaline ("pharmacokinetics") and the effect on the heart (blood pressure, heart rate, cardiac output), in food-allergic teenagers over 40kg, using auto-injector devices with 2 different needle lengths (23mm vs 15mm). 2) To assess the impact of in-hospital self-administration of adrenaline autoinjectors, in a non-reaction setting, on health-related quality of life (HRQL) measures in food-allergic teenagers and their parents.;Primary end point(s): Plasma catecholamine profile – determined through Cmax, Tmax, Area under plasma-concentration curve (AUC) – following self-injection of adrenaline (300mcg, 500mcg) on separate occasions.;Timepoint(s) of evaluation of this end point: 0-180 minutes post adrenaline injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Cardiovascular parameters [HR, BP, SV] following self-injection of adrenaline (300mcg, 500mcg) on separate occasions. 2. Plasma catecholamine levels [Cmax, Tmax, AUC] and cardiovascular parameters [HR, BP, SV] following self-injection of 300mcg adrenaline using 2 devices with different needle lengths (15mm, Epipen 0.3mg; 23mm, Emerade 300mcg). 3. Adverse events following AAI administration. 4. Change in HRQL measures (FAQLQ, FAIM, self-efficacy) 1 month following each study visit. ;Timepoint(s) of evaluation of this end point: 0-180 minutes post adrenaline injection | — |
Countries
United Kingdom
Contacts
Public ContactTurner
IMPERIAL COLLEGE LONDON
Outcome results
None listed