NCT06445374

Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges

A Phase 1b Open-Label Exploratory Study Evaluating Inhaled Epinephrine in Individuals With Known or Suspected Metabisulfite Sensitivity Experiencing Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Dr. George Luciuk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges.

Detailed description

This is a Phase 1b, single-center, open label exploratory study that will evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity and who are undergoing planned allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (food and/or drug), or oral immunotherapy (OIT). This study will enroll and dose up to 60 patients. The maximum duration of subject participation is approximately 1 week.

Conditions

• Hypersensitivity
• Anaphylaxis

Interventions

Type	Name	Description
DRUG	Inhaled Epinephrine	0.125 mg per inhalation. The maximum proposed dose to be administered is 1.0 mg (consisting of 8 inhalations of 0.125 mg over 6 minutes).

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-04-08
• Completion: 2025-04-08
• First posted: 2024-06-06
• Last updated: 2025-07-25

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study