Pharmacokinetics of Intramuscular Adrenaline in Food-Allergic Teenagers- does dose matter? The PIMAT study - PIMAT Study

Imperial College London JRC Office0 个研究点目标入组 12 人开始时间: 2017年9月15日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•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

发起方

Imperial College London JRC Office