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Inhaled Epinephrine for Allergic Reactions
Phase 1
Recruiting
Led By George H. Luciuk, MD
Research Sponsored by Dr. George Luciuk
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Uncontrolled asthma or chronic obstructive pulmonary disease (COPD)
Females who are pregnant, plan to become pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose administration to 60 minutes following first dose administration.
Awards & highlights
Summary
This trial aims to see how inhaled epinephrine affects patients who are sensitive to metabisulfite and have an allergic reaction during allergy testing or treatment.
Who is the study for?
Adults aged 18+ with known or suspected metabisulfite sensitivity and a history of systemic allergic reactions (SAR) during allergy testing, oral challenges, or immunotherapy can join. They must not be pregnant, breastfeeding, and willing to use birth control. Excluded are those sensitive to epinephrine, uncontrolled asthma/COPD patients, recent surgery recipients, individuals with severe health conditions as assessed by the investigator.
What is being tested?
The trial is exploring how inhaled epinephrine affects people who have had a moderate to severe allergic reaction while undergoing various allergy-related procedures like tests or immunotherapies.
What are the potential side effects?
Potential side effects include reactions to epinephrine such as heart palpitations, headaches, dizziness; however specific side effects for this form of inhaled treatment will be studied.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My asthma or COPD is not under control.
Select...
I am not pregnant, planning to become pregnant, or breastfeeding.
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I was hospitalized for severe asthma in the last 6 months.
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I haven't used tobacco or inhaled products like vapes or hookahs in the last year.
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I haven't had surgery in the last 90 days that could affect the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose administration to 60 minutes following first dose administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose administration to 60 minutes following first dose administration.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to resolution of systemic symptoms.
Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Inhaled EpinephrineExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Dr. George LuciukLead Sponsor
George H. Luciuk, MDPrincipal Investigator1232176 BC Ltd.
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