Trial Outcomes & Findings for Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers (NCT NCT03366298)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

3 hours

Results posted on

2022-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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	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
Overall Study STARTED	3	3	3	3
Overall Study COMPLETED	3	3	3	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Cohort n=12 Participants Overall study cohort
Age, Continuous	15.4 years n=12 Participants
Sex: Female, Male Female	5 Participants n=12 Participants
Sex: Female, Male Male	7 Participants n=12 Participants
Region of Enrollment United Kingdom	12 participants n=12 Participants
Body Mass Index	20 kg/m^2 n=12 Participants

PRIMARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome measures
Measure	Emerade 300mcg Injection n=12 Participants Self-injection with Emerade 300mcg adrenaline auto-injector	Emerade 500mcg Injection n=12 Participants Self-injection with Emerade 500mcg adrenaline auto-injector	Epipen 0.3mg n=12 Participants Self-injection with Epipen 0.3mg adrenaline auto-injector
Plasma Catecholamine Levels (Maximum Concentration, Cmax)	218 pg/ml Interval 132.0 to 359.0	394 pg/ml Interval 310.0 to 500.0	290 pg/ml Interval 200.0 to 421.0

PRIMARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome measures
Measure	Emerade 300mcg Injection n=12 Participants Self-injection with Emerade 300mcg adrenaline auto-injector	Emerade 500mcg Injection n=12 Participants Self-injection with Emerade 500mcg adrenaline auto-injector	Epipen 0.3mg n=12 Participants Self-injection with Epipen 0.3mg adrenaline auto-injector
Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax)	9.6 minutes Interval 5.3 to 17.4	8.5 minutes Interval 6.1 to 11.8	5.9 minutes Interval 4.9 to 7.3

PRIMARY outcome

Timeframe: At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes

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.

Outcome measures

Outcome measures
Measure	Emerade 300mcg Injection n=12 Participants Self-injection with Emerade 300mcg adrenaline auto-injector	Emerade 500mcg Injection n=12 Participants Self-injection with Emerade 500mcg adrenaline auto-injector	Epipen 0.3mg n=12 Participants Self-injection with Epipen 0.3mg adrenaline auto-injector
Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC))	174 hr*pg/ml Interval 86.0 to 354.0	387 hr*pg/ml Interval 263.0 to 570.0	203 hr*pg/ml Interval 142.0 to 292.0

SECONDARY outcome

Timeframe: 3 hours

Pharmacodynamics (heart rate) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

Pharmacodynamics (blood pressure) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

Pharmacodynamics (stroke volume) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

Adverse events following self-administration of adrenaline via autoinjector device defined as in protocol

Outcome measures

Outcome measures
Measure	Emerade 300mcg Injection n=12 Participants Self-injection with Emerade 300mcg adrenaline auto-injector	Emerade 500mcg Injection n=12 Participants Self-injection with Emerade 500mcg adrenaline auto-injector	Epipen 0.3mg n=12 Participants Self-injection with Epipen 0.3mg adrenaline auto-injector
Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device Pain at injection site	8 Participants	6 Participants	7 Participants
Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device Systemic AE (any)	4 Participants	9 Participants	8 Participants
Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device Palpitations	3 Participants	4 Participants	3 Participants
Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device Tremor	3 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 month

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.

Outcome measures

Outcome data not reported

Adverse Events

Emerade 300mcg Injection

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Emerade 500mcg Injection

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Epipen 0.3mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Emerade 300mcg Injection n=12 participants at risk Self-injection with Emerade 300mcg adrenaline auto-injector	Emerade 500mcg Injection n=12 participants at risk Self-injection with Emerade 500mcg adrenaline auto-injector	Epipen 0.3mg n=12 participants at risk Self-injection with Epipen 0.3mg adrenaline auto-injector
Cardiac disorders Palpitations	25.0% 3/12 • Number of events 3 • Within 24h of injection only	33.3% 4/12 • Number of events 4 • Within 24h of injection only	25.0% 3/12 • Number of events 3 • Within 24h of injection only
Nervous system disorders Tremor	25.0% 3/12 • Number of events 3 • Within 24h of injection only	58.3% 7/12 • Number of events 7 • Within 24h of injection only	66.7% 8/12 • Number of events 8 • Within 24h of injection only

Additional Information

Dr Paul Turner

Imperial College London

Phone: +44 20 3312 7754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place