Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neffy, Adrenaline.
- Who it may be relevant to
- Registry conditions: Allergic Reactions. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Neffy
Epinephrine nasal spray - Drug Adrenaline
Epinephrine injection
Primary outcome measures
- AEs after epinephrine treatment within 2 hours [Time frame: 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Orso Health, Inc. — La Jolla
- Children's National Hospital — Washington D.C.
- Endeavor Health — Glenview
- University Of Michigan — Ann Arbor
- Weill Cornell Medicine/NewYork Presbyterian Hospital — New York
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT06834165 · EPI R01