Phase 1b Open-Label Study of Inhaled Epinephrine for Systemic Allergic Reactions During Allergy Testing and Immunotherapy

What this Trial Is About

This research aims to evaluate the effects of inhaled epinephrine in individuals aged 12 years and older who experience systemic allergic reactions during allergy testing, subcutaneous immunotherapy SCIT, oral challenges, or oral immunotherapy OIT. It focuses on patients who may not be eligible for another related trial GHL-101 and seeks to better understand how inhaled epinephrine impacts these allergic events. This is a Phase 1b, open-label, multi-center exploratory study enrolling up to 100 patients. Participants receive inhaled epinephrine at doses of 0.125 mg per inhalation, with up to 8 inhalations allowed over about 6 minutes. The first dose is given quickly after identifying a Grade 2 or higher systemic allergic reaction, followed by a second dose about 10 seconds later. Inhalations continue until symptoms significantly improve or a maximum of 8 inhalations is reached, or if intramuscular epinephrine is administered. The dosing and observation happen during the participants allergy testing or immunotherapy procedures. Participants are closely observed for approximately one week during the study. Researchers monitor the time it takes for systemic symptoms to improve or completely resolve after the first dose of inhaled epinephrine. Safety assessments include vital signs and symptom evaluations. This short participation period allows researchers to gather data on inhaled epinephrines effect on allergic reactions within a controlled timeframe.

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