Allergic Reactions
Conditions
Brief summary
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.
Interventions
DRUGNeffy
Epinephrine nasal spray
DRUGAdrenaline
Epinephrine injection
Sponsors
ARS Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge. * Has body weight 15 kg or greater at the time of allergy challenge. * Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself. * Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.
Exclusion criteria
\- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs after epinephrine treatment within 2 hours | 2 hours |
Countries
United States
Contacts
CONTACTOsnat Ehrman, MSc.
Outcome results
None listed