Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherap… (NCT06445374) | Clinical Trial Compass
CompletedPhase 1
Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
Canada21 participantsStarted 2024-07-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females, aged ≥ 18 years with known or suspected metabisulfite 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) oral challenge (food and/or drug), c) oral immunotherapy (OIT) to treat existing allergies or d) subcutaneous immunotherapy (SCIT) following a prior allergic reaction AND experiences a systemic allergic reaction (SAR) rated as Grade ≥2, following allergy testing, SCIT, oral challenge (food and/or drug), or OIT, and deemed eligible for enrollment by the Principal Investigator.
✓. For females of child-bearing potential, not pregnant or lactating, willing to use a highly effective method of birth control between Screening and End-of-Study Visits.
Exclusion criteria
✕. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
✕. Known history or presence of clinically relevant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychological or other 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.
✕. Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
✕. Recent life-threatening asthma within the last 6 months which required admission to hospital prior to study start.
✕. Use of any tobacco or of any inhaled products, including vaping and water pipes (Hookahs) within 12 months prior to screening and/or a 10 pack per year history of use.
What they're measuring
1
Time to resolution of systemic symptoms.
Timeframe: From first dose administration to 60 minutes following first dose administration.
✕. Use of antihistamines within 5 days and/or bronchodilators within 24 hours of pre-challenge visit.
✕. Surgical procedures within 90 days of screening that could result in confounding of results or additional risk to the subject, 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.