Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. And to evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen).

Official Title
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Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study

Conditions
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Handling of Auto-injectors

Intervention / Treatment
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* Drug: Adrenaline auto-injector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained before entering the study 1 Prescription of EpiPen or AnaPen for at least 2 months Age ≥16 years Body weight >50 kg Subject willing and able to comply with study protocol Exclusion Criteria: Any of the following concomitant diseases: cardiovascular disease, e.g. arrhythmias or signs of coronary atherosclerosis, heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, cancer, hyperthyroidism, severe renal impairment Known blood-born infection, e.g. hepatitis and/or HIV Concomitant treatment with medication which may potentiate the effect of adrenaline, e.g. catechol-O-methyl transferase (COMT) inhibitors, monoamine oxidase (MAO) inhibitors and tricyclic antidepressants Pregnancy Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adrenaline: Session 1 Jext, 2 Epipen<br>Subjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2. | Drug: Adrenaline auto-injector<br>* Each subject will be randomly assigned to use either the Jext or EpiPen first. The alternative auto-injector will then be used by the same subject in the second study session. Valid for both Jext and Epipen: Active ingredients: Adrenaline tartrate Dosage form: Prefilled auto-injector for single use, delivering one intramuscular injection Dose/strength: 150 μg Excipients: Sodium chloride, sodium metabisulphite (E223), hydrochloric acid (for pH adjustment), water<br>* Other names: Epipen;|
| Active Comparator: Adrenaline: Session 1 Epipen, 2 Jext<br>Subjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2. | Drug: Adrenaline auto-injector<br>* Each subject will be randomly assigned to use either the Jext or EpiPen first. The alternative auto-injector will then be used by the same subject in the second study session. Valid for both Jext and Epipen: Active ingredients: Adrenaline tartrate Dosage form: Prefilled auto-injector for single use, delivering one intramuscular injection Dose/strength: 150 μg Excipients: Sodium chloride, sodium metabisulphite (E223), hydrochloric acid (for pH adjustment), water<br>* Other names: Epipen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. | The following steps were recorded as correctly done or not by the observer in a check list approach (yes/no): The subject identified the safety cap. The subject removed the safety cap. The subject identified the end of the auto-injector where the needle presents itself The subject used sufficient force to actuate the injection. The subject injected the auto-injector into the anterolateral thigh at a right angle (approximately 90°) to the thigh. The time spent for the injection of adrenaline was more than 10 seconds, i.e. with the needle in situ. If all 6 steps were performed correctly, the injection was considered as successful. These data form the basis for evaluation of the binary primary endpoint (successful injection or not). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen) regarding subject preference for one of the two auto-injectors over the other, the time to perform the injection and any hesitance to perform the injection | For evaluation of the secondary endpoints, the observer assessed the following: The time used for the actuation of the injection, i.e. the time from starting to read the instructions to having injected the adrenaline as recorded by a stop watch. This time was divided into two parts: The time for reading the information The time used to perform the injection Any hesitation from the subject to actuate the injection on a 4-step scale: None, Minor, Severe or Completely Inhibited (i.e. no injection) At the end of the second session the subject was asked the following question: Which auto-injector do you prefer? The following responses were possible: Jext / EpiPen / I don't have any preference for any of the auto-injectors. The preference is a secondary endpoint. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenaline, Auto-injector, Jext, Epipen