Recruiting
Phase 1

Inhaled Epinephrine

Sponsor:

Dr. George Luciuk

Code:

NCT07038746

Conditions

Hypersensitivity

Anaphylaxis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Inhaled Epinephrine

Study Details

Brief 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).

Conditions

Hypersensitivity

Anaphylaxis

Study ID

NCT07038746

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inhaled Epinephrine

The first inhalation will be administered as soon as possible (i.e., within approximately 30 seconds) following identification of a SAR Grade 2 or higher and confirmation of enrollment by the Principal Investigator. The second inhalation will be administered approximately 10 seconds later, and the subject will be observed for approximately 2 minutes for signs of symptom resolution.

Inhalations will continue in this manner until either:

1. resolution of systemic symptoms (defined as a reduction in SAR Grade to ≤1), or
2. if maximum number of inhalations (8 inhalations) has not been reached, complete resolution of systemic symptoms (defined as reduction in SAR Grade to 0) without exceeding maximum 8 inhalations, or
3. administration of intra-muscular epinephrine, whichever occurs earlier.

If a recurrence of symptoms is observed, administration may continue until a maximum of 8 inhalations is reached.

Interventions

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).

Primary outcome measure

  • Time to resolution of systemic symptoms [ Time Frame: From first dose administration to 60 minutes following first dose administration ]
  • Time to complete resolution of systemic symptoms [ Time Frame: From first dose administration to 60 minutes following first dose administration ]

Central Contacts and Locations

Central contacts

Locations

Kokua Pharma Inc.

Recruiting

Richmond, British Columbia, Canada, V7C 5L9

Contacts

Principal Investigator:

George H. Luciuk, MD

More Information

Sponsor

Dr. George Luciuk

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Immunotherapy
  • Epinephrine
  • Upper airway laryngeal edema
  • Upper airway pharyngeal edema
  • Hypersensitivity
  • Hypersensitivity, immediate
  • Anaphylaxis
  • Vasoconstrictor agents
  • Adrenergic alpha-Agonists
  • Adrenergic beta-Agonists
  • Bronchodilator agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. George Luciuk on 2026-08-10.