Actively Recruiting
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
Led by Dr. George Luciuk · Updated on 2026-02-05
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effects of inhaled epinephrine in individuals aged 12 years and older who experience systemic allergic reactions during allergy testing, subcutaneous immunotherapy (SCIT), oral challenges with food or drugs, or oral immunotherapy (OIT). This Phase 1b, open-label, multi-center study focuses on patients who may not qualify for the GHL-101 trial and aims to understand how inhaled epinephrine impacts these reactions. Up to 100 patients will participate, with the entire study lasting about one week per participant. Participants will receive inhaled epinephrine doses of 0.125 mg per inhalation, with a maximum of eight inhalations totaling 1.0 mg over approximately six minutes. The first inhalation occurs within about 30 seconds of identifying a systemic allergic reaction Grade 2 or higher. A second inhalation follows about 10 seconds later, and symptoms are closely monitored. Inhalations continue until symptoms resolve to Grade 1 or below, complete symptom resolution without exceeding eight inhalations, or if intramuscular epinephrine is administered. If symptoms return, dosing may resume up to the maximum allowed inhalations. During the study, participants will be observed for symptom changes following treatment. Researchers will measure the time from the first dose to symptom resolution and complete symptom resolution within 60 minutes. Safety assessments include monitoring vital signs and symptom grades. The study ensures careful observation and dosing over a short period, concluding with evaluation of inhaled epinephrine's effects on systemic allergic reactions in this specific patient group.
CONDITIONS
Brief Title
Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 12 years or older with known or suspected allergen sensitivity, including documented immunoglobulin E (IgE)-mediated allergy
- Have experienced a systemic allergic reaction Grade 2 or higher after allergy testing, subcutaneous immunotherapy, or oral challenges for oral immunotherapy
- For females of childbearing potential, not pregnant or lactating and willing to use acceptable contraception between screening and end of study
You will not qualify if you...
- Known sensitivity or allergic reaction to epinephrine or any ingredients of inhaled epinephrine
- History or presence of any clinical disease or condition that could affect study results or increase risk per Investigator judgment
- Abnormal vital signs at screening including blood pressure outside 90-140/40-90 mmHg, heart rate outside 45-100 bpm, or respiration rate outside 8-20 breaths per minute
- Females who are pregnant, plan to become pregnant, or are lactating
- Participation in another investigational drug or biologic study within 30 to 60 days prior to screening or planned participation in another interventional study during this study
- Previous treatment in this study
- Any other condition likely to affect risk-benefit, study results, or participant compliance as judged by Investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants receive inhaled epinephrine to treat systemic allergic reactions occurring during allergy testing, immunotherapy, or oral challenges. Dosing continues until symptom resolution or a maximum of 8 inhalations.
1 treatment visit (in-person) with observation for approximately 60 minutes
Trial Site Locations
Total: 1 location
1
Kokua Pharma Inc.
Richmond, British Columbia, Canada, V7C 5L9
Actively Recruiting
Research Team
G
George H. Luciuk, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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