HypersensitivityPhase 1NCT06445374
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 purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges. Read more about this study
- Who is it for?
- Ages 18 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
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2024to 8 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged ≥ 18 years with known or suspected metabisulfite 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) oral challenge (food and/or drug), c) oral immunotherapy (OIT) to treat existing allergies or d) subcutaneous immunotherapy (SCIT) following a prior allergic reaction AND experiences a systemic allergic reaction (SAR) rated as Grade ≥2, following allergy testing, SCIT, oral challenge (food and/or drug), or OIT, and deemed eligible for enrollment by the Principal Investigator.
- For females of child-bearing potential, not pregnant or lactating, willing to use a highly effective method of birth control 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 relevant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychological or other 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.
- Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
- Recent life-threatening asthma within the last 6 months which required admission to hospital prior to study start.
- Use of any tobacco or of any inhaled products, including vaping and water pipes (Hookahs) within 12 months prior to screening and/or a 10 pack per year history of use.
- Use of antihistamines within 5 days and/or bronchodilators within 24 hours of pre-challenge visit.
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- Surgical procedures within 90 days of screening that could result in confounding of results or additional risk to the subject, 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 unfavourably 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.
About this study
Official title: A Phase 1b Open-Label Exploratory Study Evaluating Inhaled Epinephrine in Individuals With Known or Suspected Metabisulfite Sensitivity Experiencing Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges.
Read the detailed description
This is a Phase 1b, single-center, open label exploratory study that will evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity and who are undergoing planned allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (food and/or drug), or oral immunotherapy (OIT). This study will enroll and dose up to 60 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 Grade 2 or greater SAR 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. maximum number of inhalations (8 inhalations) is reached, or
3. administration of intra-muscular epinephrine, whichever occurs earlier 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.
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 posted6 Jun 2024
- Study start15 Jul 2024
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
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
- 21 participants (actual)
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
- NCT06445374
- Sponsor's protocol ID
- GHL-101
- Status last verified
- Jul 2025
- First submitted
- 30 May 2024
- Last updated
- 25 Jul 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label Exploratory Study Evaluating Inhaled Epinephrine in Individuals With Known or Suspected Metabisulfite Sensitivity Experiencing Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
- ClinicalTrials.gov ID
- NCT06445374
- Acronym / sponsor ID
- GHL-101
- Conditions
- Hypersensitivity, Anaphylaxis
- Keywords
- Immunotherapy, Epinephrine, Upper airway laryngeal edema, Upper airway pharyngeal edema, Hypersensitivity, Hypersensitivity, immediate, Anaphylaxis, Vasoconstrictor agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Dr. George LuciukUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges.
Detailed description
This is a Phase 1b, single-center, open label exploratory study that will evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity and who are undergoing planned allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (food and/or drug), or oral immunotherapy (OIT). This study will enroll and dose up to 60 patients.
The maximum duration of subject participation is approximately 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Epinephrine | Experimental | Drug: Inhaled EpinephrineThe first inhalation will be administered as soon as possible (i.e., within approximately 30 seconds) following identification of a Grade 2 or greater SAR 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. maximum number of inhalations (8 inhalations) is reached, or 3. administration of intra-muscular epinephrine, whichever occurs earlier |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, aged ≥ 18 years with known or suspected metabisulfite 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) oral challenge (food and/or drug), c) oral immunotherapy (OIT) to treat existing allergies or d) subcutaneous immunotherapy (SCIT) following a prior allergic reaction AND experiences a systemic allergic reaction (SAR) rated as Grade ≥2, following allergy testing, SCIT, oral challenge (food and/or drug), or OIT, and deemed eligible for enrollment by the Principal Investigator.
- For females of child-bearing potential, not pregnant or lactating, willing to use a highly effective method of birth control between Screening and End-of-Study Visits.
Key exclusion criteria (12 listed)
- Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
- Known history or presence of clinically relevant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychological or other 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.
- Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
- Recent life-threatening asthma within the last 6 months which required admission to hospital prior to study start.
- Use of any tobacco or of any inhaled products, including vaping and water pipes (Hookahs) within 12 months prior to screening and/or a 10 pack per year history of use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Epinephrine0.125 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). | Drug | Inhaled Epinephrine |
Primary outcome
Time to resolution of systemic symptoms.
Time frame: From first dose administration to 60 minutes following first dose administration.
Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George H. Luciuk, MD principal investigator
Kokua Pharma Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled Epinephrine in people with Hypersensitivity and Anaphylaxis, run by Dr. George Luciuk at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of systemic symptoms. (time frame: From first dose administration to 60 minutes following first dose administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.