Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges

Launched by DR. GEORGE LUCIUK · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of inhaled epinephrine (a medicine that helps quickly treat serious allergic reactions) in people who experience strong allergic reactions during allergy testing or allergy treatments like shots or food challenges. The study is for individuals aged 12 and older who have allergies confirmed by tests or previous allergic reactions. It focuses on those who have had a significant allergic reaction (called a systemic allergic reaction) after allergy testing, allergy shots, or food/drug challenges, and who may not be able to join another related trial.

If you join this study, you can expect to be carefully monitored while using inhaled epinephrine to see how well it works and how safe it is in these situations. Women who can become pregnant will be asked to use birth control during the study to ensure safety. People with certain health issues, abnormal vital signs, or known problems with epinephrine won’t be able to participate. This study is not yet recruiting, but it aims to help improve emergency treatment options for allergic reactions during allergy testing and treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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).
• • 2. 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 enrollment by the Principal Investigator.
• • 3. For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception\* method between Screening and End-of-Study Visits.
• Exclusion Criteria:
• • 1. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
• • 2. 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 Investigator.
• • 3. 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.
• • 4. Females who are pregnant, plan to become pregnant or lactating.
• • 5. 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.
• • 6. Previous treatment in this study.
• • 7. 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.