Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorDr. George Luciuk
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception* method between Screening and End-of-Study Visits.
Disqualifiers
Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
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.
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.
Females who are pregnant, plan to become pregnant or lactating.
Trial design
Design model
Single group
Treatments tested in this trial
Inhaled Epinephrine
Drug0.125 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).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Inhaled EpinephrineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time 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 administration2
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 administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. George Luciuk
Lead sponsor
Kokua Pharma Inc.
Sponsor institution
Source ClinicalTrials.gov