The goal of this exploratory study is to evaluate the effects of inhaled epinephrine in subjects, who may not be eligible for the GHL-101 trial, and who are experiencing systemic allergic reaction (SAR) that occur following allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (with food and/or drug) or oral immunotherapy (OIT).
This is a Phase 1b, multi-center, open label exploratory study evaluating the effects of inhaled epinephrine in patients who are undergoing planned allergy testing, SCIT, oral challenges (with food and/or drug), or OIT and are not eligible for the GHL-101 study. This study will enroll and dose up to 100 patients. The maximum duration of subject participation is approximately 1 week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
0.125 mg per inhalation. The maximum proposed dose to be administered is 1.0 mg (consisting of 8 inhalations of 0.125 mg over 6 minutes).
Kokua Pharma Inc.
Richmond, British Columbia, Canada
RECRUITINGTime to resolution of systemic symptoms
Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Time frame: From first dose administration to 60 minutes following first dose administration
Time to complete resolution of systemic symptoms
Defined as a reduction in systemic allergic reaction (SAR) Grade to 0. Grade 0 is considered the absence of any symptoms and per World Allergy Organisation's Grading System for Systemic Allergic Reactions, Grade 1 is least severe and Grade 5 is most severe.
Time frame: From first dose administration to 60 minutes following first dose administration
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