Pharmacokinetics of Intramuscular Adrenaline in Food-Allergic Teenagers- does dose matter? The PIMAT study
- Conditions
- AnaphylaxisMedDRA version: 20.0Level: LLTClassification code 10000664Term: Acute anaphylaxisSystem Organ Class: 100000023018Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-003239-13-GB
- Lead Sponsor
- Imperial College London JRC Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method