Inhaled epinephrine for 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

This will see if inhaled epinephrine helps people 12 and older who have systemic allergic reactions during allergy testing, subcutaneous or oral immunotherapy, or oral food/drug challenges.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Kokua Pharma Inc. (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Richmond, British Columbia)
• Trial ID: NCT07038746 on ClinicalTrials.gov

What this trial studies

This Phase 1b, open-label, multi-center exploratory study will enroll up to 100 patients who experience a Grade 2 or higher systemic allergic reaction during planned allergy testing, SCIT, OIT, or oral challenges and who are not eligible for the GHL-101 protocol. Enrolled participants will receive inhaled epinephrine at the time of an eligible systemic allergic reaction and will be observed for safety and clinical effects. The maximum participation period for each subject is approximately one week, and dosing and monitoring procedures will be recorded at study visits. The study is intended to characterize tolerability, immediate clinical response, and feasibility of the inhaled route in this acute setting.

Who should consider this trial

Good fit: People aged 12 and older with known or suspected IgE-mediated allergies who experience a Grade 2 or higher systemic allergic reaction during planned allergy testing, subcutaneous immunotherapy, oral immunotherapy, or oral challenge and are judged eligible by the investigator.

Not a fit: Individuals with a known allergy or sensitivity to epinephrine, those with medical conditions that contraindicate epinephrine (such as certain cardiovascular disease), and pregnant or breastfeeding people are unlikely to benefit or will be excluded.

Why it matters

Potential benefit: If successful, inhaled epinephrine could offer a quick, non-invasive way to treat airway and systemic allergic reactions that may reduce reliance on injectable epinephrine and emergency interventions.

How similar studies have performed: Prior clinical data on inhaled epinephrine for systemic allergic reactions are limited and mostly small or focused on upper airway symptoms, so this application remains exploratory.

Eligibility criteria

Inclusion Criteria:

1. Males or females, aged ≥ 12 years with known or suspected allergen sensitivity who can also have a clinical history of immunoglobulin E (IgE)-mediated allergy, including a documented sensitivity to allergens (i.e., positive skin prick test, or positive in vitro serum IgE).
2. Have undergone either a) allergy testing for suspected sensitivity/allergy, b) future oral challenge (food and/or drug) or future OIT to treat existing allergies or c) SCIT AND experienced a SAR Grade 2 or higher, following allergy testing, SCIT, or oral challenges (food and/or drug) for future OIT, and deemed eligible for enrollment by the Principal Investigator.
3. For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception\* method between Screening and End-of-Study Visits.

Exclusion Criteria:

1. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
2. Known history or presence of clinically disease/condition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.
3. Abnormal vital signs at screening (i.e., systolic blood pressure: \< 90 or \>140 mmHg, diastolic blood pressure: \< 40 or \> 90 mmHg or, heart rate: \< 45 or \> 100 bpm), respiration rate \< 8 or \> 20 resp./min.
4. Females who are pregnant, plan to become pregnant or lactating.
5. Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current/planned participation in another interventional study during this study.
6. Previous treatment in this study.
7. Any other reason that, in the opinion of the Investigator, is likely to unfavorably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.

Where this trial is running

Richmond, British Columbia

• Kokua Pharma Inc. — Richmond, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: George H. Luciuk, MD — Kokua Pharma Inc.
• Study coordinator: George H. Luciuk, MD

Conditions Hypersensitivity; Anaphylaxis; Immunotherapy; Epinephrine; Upper airway laryngeal edema; Upper airway pharyngeal edema; Hypersensitivity, immediate; Vasoconstrictor agents