Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4+
SponsorARS Pharmaceuticals, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neffy

    Drug

    Epinephrine nasal spray

  • Adrenaline

    Drug

    Epinephrine injection

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: NeffyActive comparator 1 intervention
Group B: IM adrenalineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

AEs after epinephrine treatment within 2 hours

Time frame
2 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.