Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366298
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2017-11-21
Brief Title:
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers Does Dose Matter
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIMAT
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 which can be fatal Adrenaline epinephrine 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 epinephrine administration during anaphylaxis are risk factors for fatal anaphylaxis
In 2010 a coroners investigation into the death of a food-allergic teenager in the UK raised several questions around AAI safety and efficacy since the teenager died despite administering her auto-injector device This prompted a review by the Medicines and Healthcare products Regulatory Agency 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 05mg dose AAI In the UK currently only Emerade one of the three companies selling AAIs manufactures a 05mg 500mcg version Emerade also has a longer needle length 23mm compared to other AAIs typically 15mm
The investigators plan to formally assess the pharmacokinetics PK and pharmacodynamics PD of self-injection with intramuscular adrenaline epinephrine in teenagers at risk of anaphylaxis due to food allergy and have been prescribed AAI
1 The investigators will compare self-injection with 300mcg vs 500mcg in teenagers of body weight 40kg In a 40kg person an adrenaline dose of 300mcg results in an effective UNDER-dosing of 30 by body weight
2 The investigators 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
In 2010 a coroners investigation into the death of a food-allergic teenager in the UK raised several questions around AAI safety and efficacy since the teenager died despite administering her auto-injector device This prompted a review by the Medicines and Healthcare products Regulatory Agency 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 05mg dose AAI In the UK currently only Emerade one of the three companies selling AAIs manufactures a 05mg 500mcg version Emerade also has a longer needle length 23mm compared to other AAIs typically 15mm
The investigators plan to formally assess the pharmacokinetics PK and pharmacodynamics PD of self-injection with intramuscular adrenaline epinephrine in teenagers at risk of anaphylaxis due to food allergy and have been prescribed AAI
1 The investigators will compare self-injection with 300mcg vs 500mcg in teenagers of body weight 40kg In a 40kg person an adrenaline dose of 300mcg results in an effective UNDER-dosing of 30 by body weight
2 The investigators 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003239-13 | EUDRACT_NUMBER | None | None |
| 232931 | OTHER | HRA | None |