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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003239-13 | EudraCT Number | ||
| 232931 | Other Identifier | HRA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Visit 1: Emerade 300mcg then Epipen 0.3mg Visit 2: Emerade 500mcg |
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| 2 | Active Comparator | Visit 1: Epipen 0.3mg then Emerade 300mcg Visit 2: Emerade 500mcg |
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| 3 | Active Comparator | Visit 1: Emerade 500mcg Visit 2: Emerade 300mcg then Epipen 0.3mg |
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| 4 | Active Comparator | Visit 1: Emerade 500mcg Visit 2: Epipen 0.3mg then Emerade 300mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epipen 0.3mg | Combination Product | Epipen 0.3mg auto-injector |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 hours |
| Change in Blood Pressure Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Turner, FRACP PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London / Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36794963 | Derived | Patel N, Isaacs E, Duca B, Nagaratnam N, Donovan J, Fontanella S, Turner PJ. Optimal dose of adrenaline auto-injector for children and young people at risk of anaphylaxis: A phase IV randomized controlled crossover study. Allergy. 2023 Jul;78(7):1997-2006. doi: 10.1111/all.15675. Epub 2023 Feb 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Emerade 300 / Epipen 0.3mg / Emerade 500 | Visit 1: Emerade 300mcg then Epipen 0.3mg Visit 2: Emerade 500mcg Epipen 0.3mg: Epipen 0.3mg auto-injector Emerade 300mcg: Emerade 300mcg auto-injector Emerade 500mcg: Emerade 500mcg auto-injector |
| FG001 | Epipen 0.3mg / Emerade 300 / Emerade 500 | Visit 1: Epipen 0.3mg then Emerade 300mcg Visit 2: Emerade 500mcg Epipen 0.3mg: Epipen 0.3mg auto-injector Emerade 300mcg: Emerade 300mcg auto-injector Emerade 500mcg: Emerade 500mcg auto-injector |
| FG002 | Emerade 500 / Emerade 300 / Epipen 0.3mg | Visit 1: Emerade 500mcg Visit 2: Emerade 300mcg then Epipen 0.3mg Epipen 0.3mg: Epipen 0.3mg auto-injector Emerade 300mcg: Emerade 300mcg auto-injector Emerade 500mcg: Emerade 500mcg auto-injector |
| FG003 | Emerade 500 / Epipen 0.3mg / Emerade 300 | Visit 1: Emerade 500mcg Visit 2: Epipen 0.3mg then Emerade 300mcg Epipen 0.3mg: Epipen 0.3mg auto-injector Emerade 300mcg: Emerade 300mcg auto-injector Emerade 500mcg: Emerade 500mcg auto-injector |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Cohort | Overall study cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | pg/ml | 3 hours |
|
Within 24h of injection only
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emerade 300mcg Injection | Self-injection with Emerade 300mcg adrenaline auto-injector |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Turner | Imperial College London | +44 20 3312 7754 | p.turner@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2017 | Nov 28, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Emerade 300mcg | Combination Product | Emerade 300mcg auto-injector |
|
|
| Emerade 500mcg | Combination Product | Emerade 500mcg auto-injector |
|
|
Pharmacodynamics (blood pressure) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 1 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
Self-injection with Epipen 0.3mg adrenaline auto-injector |
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | minutes | 3 hours |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | hr*pg/ml | At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes |
|
|
|
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | 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. | Not Posted | 3 hours | Participants |
| Secondary | Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device | Adverse events following self-administration of adrenaline via autoinjector device defined as in protocol | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | 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. | Not Posted | 1 month | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Emerade 500mcg Injection | Self-injection with Emerade 500mcg adrenaline auto-injector | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | Epipen 0.3mg | Self-injection with Epipen 0.3mg adrenaline auto-injector | 0 | 12 | 0 | 12 | 8 | 12 |
| Tremor | Nervous system disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| Palpitations |
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| Tremor |
|