A Phase IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
ARS Pharmaceuticals, Inc.
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.
Eligibility
- Age range
- 4+ years
- Sex
- All
- 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…
Interventions
- DrugNeffy
Epinephrine nasal spray
- DrugAdrenaline
Epinephrine injection
Locations (6)
- Orso Health, Inc.La Jolla, California
- Children's National HospitalWashington D.C., District of Columbia
- Endeavor HealthGlenview, Illinois
- University Of MichiganAnn Arbor, Michigan
- Weill Cornell Medicine/NewYork Presbyterian HospitalNew York, New York
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio