PIMAT Study
Research type
Research Study
Full title
Pharmacokinetics of Intramuscular Adrenaline in Food-Allergic Teenagers\n- does dose matter? The PIMAT study\n
IRAS ID
232931
Contact name
Paul Turner
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Eudract number
2017-003239-13
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
Food allergy affects up to 2% of adults and 8% of children in the UK, and is a major public health issue. It is the commonest cause of life-threatening allergic reactions (anaphylaxis), which can be fatal. Adrenaline auto-injector (AAI) devices are the first-line treatment for anaphylaxis, yet in a UK survey, over 80% of 245 teenagers experiencing anaphylaxis did not use their AAI. Delays in, or lack of adrenaline administration during anaphylaxis are risk factors for fatal anaphylaxis.\n\nIn 2010, a teenager died from food-induced anaphylaxis despite administering her auto-injector device. The coroner raised several questions around AAI safety and efficacy, which prompted a review by the MHRA in 2014 into the clinical and quality considerations of AAIs. Two recommendations which came from the review was that companies ‘should be encouraged to develop a 0.5mg [dose] AAI.’ In the UK currently only Emerade, one of the three companies selling AAIs, manufactures a 0.5mg (500mcg) version. Emerade also has a longer needle length (23mm) compared to other AAIs (typically 15mm).\n\nWe wish to formally assess the pharmacokinetics (PK) and pharmacodynamics (PD) of self-injection with intramuscular adrenaline in teenagers at risk of anaphylaxis due to food allergy, and have been prescribed AAI.\n1.\tWe will compare self-injection with 300mcg vs 500mcg in teenagers of body weight >40kg. We have chosen this weight cut-off as our local Network guidance is to consider switching teenagers over to a 500mcg device from 40-45kg. It should be noted that in a 40kg person, an adrenaline dose of 300mcg results in an effective UNDER-dosing of 30% by body weight.\n2.\tWe will also assess the impact of needle length on injection, by comparing two different devices, both of which deliver 300mcg, but one via a 15mm needle and the other with a 23mm needle.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1568
Date of REC Opinion
19 Sep 2017
REC opinion
Favourable Opinion