NCT07038746

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

A Phase 1b, Open-Label, Exploratory Study Evaluating the Effects of Inhaled Epinephrine in Individuals Experiencing Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Dr. George Luciuk · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this exploratory study is to evaluate the effects of inhaled epinephrine in subjects, who may not be eligible for the GHL-101 trial, and who are experiencing systemic allergic reaction (SAR) that occur following allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (with food and/or drug) or oral immunotherapy (OIT).

Detailed description

This is a Phase 1b, multi-center, open label exploratory study evaluating the effects of inhaled epinephrine in patients who are undergoing planned allergy testing, SCIT, oral challenges (with food and/or drug), or OIT and are not eligible for the GHL-101 study. This study will enroll and dose up to 100 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: 2025-08-25
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-06-26
• Last updated: 2026-02-05

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study