Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445374
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
Sponsor:
Dr George Luciuk
Organization:
1232176 BC Ltd
Study Overview
Official Title:
A Phase 1b Open-Label Exploratory Study Evaluating Inhaled Epinephrine in Individuals With Known or Suspected Metabisulfite Sensitivity Experiencing Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction SAR while undergoing allergy testing immunotherapy or oral challenges
Detailed Description:
This is a Phase 1b single-center open label exploratory study that will evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity and who are undergoing planned allergy testing subcutaneous immunotherapy SCIT oral challenges food andor drug or oral immunotherapy OIT This study will enroll and dose up to 60 patients
The maximum duration of subject participation is approximately 1 week
The maximum duration of subject participation is approximately 1 week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None