Testing Inhaled Epinephrine for hypersensitivity
Official title: Effects of Inhaled Epinephrine on 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
- Phase 1
- 1 group
- One site, in Richmond
- Recruiting
Interventions
- Medication
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).
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Kokua Pharma Inc.
Richmond, British Columbia
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → by the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception\* method between ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → and End-of-Study Visits.
Exclusion
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- −Abnormal vital signs at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (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.
- −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 studyInterventional studyA study where participants are given something to see what happens.Read more → 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.
- −Females who are pregnant, plan to become pregnant or lactating.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Inhaled Epinephrine.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 12 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around January 2027.
The main measurement is taken over: From first dose administration to 60 minutes following first dose administration.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to resolution of systemic symptoms — measured over From first dose administration to 60 minutes following first dose administration.
Time to complete resolution of systemic symptoms — measured over From first dose administration to 60 minutes following first dose administration.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07038746 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 12 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 12 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From first dose administration to 60 minutes following first dose administration.
The study as a whole is currently expected to finish around 2027-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Richmond, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.