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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

No Placebo-Only Group

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:

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My asthma or COPD is not under control.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose administration to 60 minutes following first dose administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to resolution of systemic symptoms.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met