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The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neffy | Active Comparator |
| |
| IM adrenaline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neffy | Drug | Epinephrine nasal spray |
| |
| Adrenaline |
| Measure | Description | Time Frame |
|---|---|---|
| AEs after epinephrine treatment within 2 hours | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osnat Ehrman, MSc. | Contact | 952.334.5797 | osnate@pacificlinkconsulting.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orso Health, Inc. | Recruiting | La Jolla | California | 92037 | United States |
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| Drug |
Epinephrine injection |
|
| Children's National Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Endeavor Health | Recruiting | Glenview | Illinois | 60026 | United States |
|
| University Of Michigan | Recruiting | Ann Arbor | Michigan | 48105 | United States |
|
| Weill Cornell Medicine/NewYork Presbyterian Hospital | Recruiting | New York | New York | 10021 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
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