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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenaline: Session 1 Jext, 2 Epipen | Active Comparator | Subjects will be randomised 1:1 to use Jext in session 1 and EpiPen in session 2. |
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| Adrenaline: Session 1 Epipen, 2 Jext | Active Comparator | Subjects will be randomised 1:1 to use EpiPen in session 1 and Jext in session 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenaline auto-injector | Drug | 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 |
| 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):
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 |
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of instructions and AEs | After the injection the subject evaluated the package of instructions (leaflet as well as the information on the auto-injector) for the following (yes/no): Were the instructions concise? Were the instructions comprehensible? Do you have any further questions concerning the instructions or do you see any lack of clarity? These have been assessed as other endpoints. Safety assessments included recording of all AEs and serious adverse events (SAEs) were done. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Strand, MD Phd | Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Allergy Clinic at St Göran's Hospital | Stockholm | 11281 | Sweden |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| 1 day |
| 1 day |
| 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 |