A Phase 4 interventional study of Epipen 0.3mg and Emerade 300mcg in Anaphylaxis, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Imperial College London · Phase 4, Interventional, and Treatment
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 coroner's 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 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).
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.
100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 50 interventional studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Visit 1: Emerade 300mcg then Epipen 0.3mg Visit 2: Emerade 500mcg
Combination Product: Epipen 0.3mg · Combination Product: Emerade 300mcg · Combination Product: Emerade 500mcg
Visit 1: Epipen 0.3mg then Emerade 300mcg Visit 2: Emerade 500mcg
Combination Product: Epipen 0.3mg · Combination Product: Emerade 300mcg · Combination Product: Emerade 500mcg
Visit 1: Emerade 500mcg Visit 2: Emerade 300mcg then Epipen 0.3mg
Combination Product: Epipen 0.3mg · Combination Product: Emerade 300mcg · Combination Product: Emerade 500mcg
Visit 1: Emerade 500mcg Visit 2: Epipen 0.3mg then Emerade 300mcg
Combination Product: Epipen 0.3mg · Combination Product: Emerade 300mcg · Combination Product: Emerade 500mcg
Epipen 0.3mg auto-injector
Also known as: Epinephrine
Emerade 300mcg auto-injector
Also known as: Epinephrine
Emerade 500mcg auto-injector
Also known as: Epinephrine
Plasma Catecholamine Levels (Maximum Concentration, Cmax)
Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Time frame: 3 hours
Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax)
Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Time frame: 3 hours
Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC))
Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. Baseline corrected.
Time frame: At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes
Change in Heart Rate Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions.
Pharmacodynamics (heart rate) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Time frame: 3 hours
Change in Blood Pressure Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions.
Pharmacodynamics (blood pressure) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Time frame: 3 hours
Change in Stroke Volume Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions.
Pharmacodynamics (stroke volume) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Time frame: 3 hours
Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: Cmax)
Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Time frame: 3 hours
Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: Tmax)
Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Time frame: 3 hours
Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: AUC)
Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Time frame: 3 hours
Impact of Needle Length on Pharmacodynamics (Cardiovascular Parameters: Heart Rate)
The pharmacodynamics (cardiovascular parameters: heart rate) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Time frame: 3 hours
Impact of Needle Length on Pharmacodynamics (Cardiovascular Parameters: Blood Pressure)
The pharmacodynamics (cardiovascular parameters: blood pressure) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Time frame: 3 hours
Impact of Needle Length on Pharmacodynamics (Cardiovascular Parameters: Stroke Volume)
The pharmacodynamics (cardiovascular parameters: stroke volume) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Time frame: 3 hours
Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device
Adverse events following self-administration of adrenaline via autoinjector device defined as in protocol
Time frame: 1 day
Change in Health-related Quality of Life (HRQL) as Measured Using FAQLQ
The impact of 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.
Time frame: 1 month
| Milestone | Emerade 300 / Epipen 0.3mg / Emerade 500 | Epipen 0.3mg / Emerade 300 / Emerade 500 | Emerade 500 / Emerade 300 / Epipen 0.3mg | Emerade 500 / Epipen 0.3mg / Emerade 300 |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
| pg/ml | Emerade 300mcg Injection | Emerade 500mcg Injection | Epipen 0.3mg |
|---|---|---|---|
| Plasma Catecholamine Levels (Maximum Concentration, Cmax) | 218 (132 to 359) | 394 (310 to 500) | 290 (200 to 421) |
Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
| minutes | Emerade 300mcg Injection | Emerade 500mcg Injection | Epipen 0.3mg |
|---|---|---|---|
| Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) | 9.6 (5.3 to 17.4) | 8.5 (6.1 to 11.8) | 5.9 (4.9 to 7.3) |
Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. Baseline corrected.
| hr*pg/ml | Emerade 300mcg Injection | Emerade 500mcg Injection | Epipen 0.3mg |
|---|---|---|---|
| Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) | 174 (86 to 354) | 387 (263 to 570) | 203 (142 to 292) |
Pharmacodynamics (heart rate) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
Pharmacodynamics (blood pressure) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
Pharmacodynamics (stroke volume) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
The pharmacodynamics (cardiovascular parameters: heart rate) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
The pharmacodynamics (cardiovascular parameters: blood pressure) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
The pharmacodynamics (cardiovascular parameters: stroke volume) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg.
Results for this outcome have not been posted.
Adverse events following self-administration of adrenaline via autoinjector device defined as in protocol
| Participants | Emerade 300mcg Injection | Emerade 500mcg Injection | Epipen 0.3mg |
|---|---|---|---|
| Pain at injection site | 8 | 6 | 7 |
| Systemic AE (any) | 4 | 9 | 8 |
| Palpitations | 3 | 4 | 3 |
| Tremor | 3 | 7 | 8 |
The impact of 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.
Results for this outcome have not been posted.
Collected over Within 24h of injection only. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Emerade 300mcg Injection | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Emerade 500mcg Injection | 0/12 (0%) | 0/12 (0%) | 9/12 (75%) |
| Epipen 0.3mg | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Event | Emerade 300mcg Injection | Emerade 500mcg Injection | Epipen 0.3mg |
|---|---|---|---|
| TremorNervous system disorders | 3/12 | 7/12 | 8/12 |
| PalpitationsCardiac disorders | 3/12 | 4/12 | 3/12 |
| Age, Continuous(years) | Overall Cohort |
|---|---|
| Median | 15.4 (13.3 to 18.3) |
| Sex: Female, Male(Participants) | Overall Cohort |
|---|---|
| Female | 5 |
| Male | 7 |
| Race and Ethnicity Not Collected(Participants) | Overall Cohort |
|---|
| Region of Enrollment(participants) | Overall Cohort |
|---|---|
| United Kingdom | 12 |
| Body Mass Index(kg/m^2) | Overall Cohort |
|---|---|
| Median | 20 (16.1 to 27.5) |
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Studies of the drug tested here: Epinephrine