Inhaled Epinephrine for Anaphylaxis

Overseen By George H. Luciuk, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Dr. George Luciuk

Disqualifiers: Epinephrine sensitivity, Abnormal vital signs, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how inhaled epinephrine can assist individuals experiencing severe allergic reactions (systemic allergic reactions) after allergy testing, oral challenges, or immunotherapy treatments. The goal is to determine if inhaling this medication can quickly reduce symptoms without requiring an injection. It suits individuals aged 12 years or older with a history of allergies and significant allergic reactions during these procedures. This trial may interest those seeking an alternative to injections during allergic episodes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that inhaled epinephrine is likely to be safe for humans?

Research has shown that inhaled epinephrine is usually well-tolerated. One study found that it quickly spreads the medicine throughout the body and has noticeable effects in healthy volunteers, indicating that most people can use it without major problems.

Another review indicates that using epinephrine for severe allergic reactions, like anaphylaxis, is safe. Early use is important because it helps stop symptoms and lowers the chance of recurrence.

While strong evidence supports the safety of epinephrine in general, this trial is in its early stages. It primarily focuses on understanding the safety of inhaled epinephrine for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Inhaled epinephrine is unique because it offers a new delivery method for treating anaphylaxis, potentially providing quicker relief compared to the traditional intramuscular injection. This inhalation approach could make it easier for patients to administer the treatment themselves during an allergic reaction. Researchers are excited about this treatment because it could simplify the process and improve the speed of symptom resolution, making it a game-changer for those who suffer from severe allergies.

What evidence suggests that inhaled epinephrine might be an effective treatment for systemic allergic reactions?

Research shows that inhaled epinephrine, which participants in this trial will receive, could be a promising treatment for severe allergic reactions. Studies have found that other forms of epinephrine, such as nasal sprays, are effective and easy to use for these conditions. This suggests that inhaled epinephrine might work similarly. Evidence from other delivery methods of epinephrine has demonstrated rapid symptom relief, often within minutes. Although direct data on inhaled epinephrine is limited, these findings support its potential effectiveness in managing allergic reactions. ^{6 7 8 9 10}

Who Is on the Research Team?

George H. Luciuk, MD

Principal Investigator

Kokua Pharma Inc.

Are You a Good Fit for This Trial?

This trial is for individuals experiencing systemic allergic reactions during allergy testing, immunotherapy, or oral challenges. Specific eligibility criteria are not provided, but typically participants would have a history of allergies or anaphylaxis.

Inclusion Criteria

I am 12 or older with allergies confirmed by tests.

For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception method between Screening and End-of-Study Visits

I have had a severe allergic reaction after allergy testing or treatment.

Exclusion Criteria

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

I am not pregnant, planning to become pregnant, or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive inhaled epinephrine during systemic allergic reactions

1 week

Single visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 hour

Observation period post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Inhaled Epinephrine

Trial Overview The study investigates the effects of inhaled epinephrine on people having allergic reactions that aren't severe enough for another trial (GHL-101). It's exploratory and includes those undergoing various allergy-related procedures.

How Is the Trial Designed?

Group I: Inhaled Epinephrine Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Dr. George Luciuk

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8139870/

Evidence update for the treatment of anaphylaxis - PMC Coronial inquests have identified that the use of AAIs for anaphylaxis can therefore result in substantial underdosing, which may contribute to fatal outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120624017150

A health economic analysis of noninjectable epinephrine ... The base-case assumed exaggerated anaphylaxis fatality rates (50-fold increase) for using inhaled epinephrine given low certainty evidence in anaphylaxis and ...

3. journals.lww.com journals.lww.com/co-allergy/fulltext/2025/12000/epinephrine_nasal_spray_for_the_treatment_of.11.aspx

Epinephrine nasal spray for the treatment of anaphylaxis:... According to recent research, intranasal epinephrine represents an easy-to-use, effective, and well tolerated treatment for severe allergic reactions.

4. annallergy.org annallergy.org/article/S1081-1206(23)00404-0/fulltext

Innovations in the treatment of anaphylaxis: A review ... Data from these studies indicate promising pharmacokinetic results comparable to those of the standard of outpatient emergency care (0.3-mg EAI) ...

5. jacionline.org jacionline.org/article/S0091-6749(24)01863-3/fulltext

Superior Efficacy of Epinephrine Nasal Spray for the Relief ... Conclusions. Relative to a matched control group, patients receiving neffy as an initial treatment had lower symptom scores within 10 minutes. These data ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482124/

Anaphylaxis - StatPearls - NCBI Bookshelf - NIH If epinephrine is required, as in cases of anaphylaxis, complete resolution is noted. Emergency department observation for 4 hours is recommended.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825003757

Benefits of Epinephrine for Anaphylaxis Outweigh Potential ... Therefore, the objective of this narrative review is to describe the safety of epinephrine when administered for the treatment of anaphylaxis.

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06445374

Effects of Inhaled Epinephrine on Systemic Allergic ... The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who ...

9. investor.alkermes.com investor.alkermes.com/news-releases/news-release-details/alkermes-presents-positive-clinical-data-inhaled-form

Alkermes Presents Positive Clinical Data for Inhaled Form ... AIR Epinephrine demonstrated rapid systemic delivery associated with clinically meaningful pharmacodynamic responses in normal volunteers.

10. annallergy.org annallergy.org/article/S1081-1206(23)01304-2/fulltext

Anaphylaxis: A 2023 practice parameter update Available evidence suggests that early epinephrine use for anaphylaxis may improve clinical outcomes by decreasing risk of biphasic reactions ...