HypersensitivityPhase 1NCT07038746
Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
A Phase 1 study testing Inhaled Epinephrine in people with Hypersensitivity and Anaphylaxis, run by Dr. George Luciuk at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hypersensitivity, Anaphylaxis
- What is being tested?
- Inhaled Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2025to Jan 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
- 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.
- For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception* method between Screening and End-of-Study Visits.
Who cannot join
- Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
- 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.
- 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.
- Females who are pregnant, plan to become pregnant or lactating.
- 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.
- Previous treatment in this study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Kokua Pharma Inc.
Richmond, British Columbia, V7C 5L9
George H. Luciuk, MD, 1-604-270-7801, gh.luciuk@dr.com
George H. Luciuk, MD
About this study
Official title: 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
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).
Read the 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
- Being tested
- Inhaled Epinephrine
- 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
- Medical subject headings
- Hypersensitivity, Anaphylaxis, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled EpinephrineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Epinephrine | Experimental | 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. Receives: Drug: Inhaled Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of systemic symptoms
Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Measured: From first dose administration to 60 minutes following first dose administration
Time to complete resolution of systemic symptoms
Defined as a reduction in systemic allergic reaction (SAR) Grade to 0. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Measured: From first dose administration to 60 minutes following first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start25 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. George Luciuk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. George Luciuk, Kokua Pharma Inc.
- Investigators
- George H. Luciuk, MD, Principal investigator, Kokua Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038746
- Sponsor's protocol ID
- GHL-102
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial, after deidentification.