[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595922":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":31,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Kokua Pharma Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Inhaled Epinephrine","EXPERIMENTAL","The first inhalation will be administered as soon as possible (i.e., within approximately 30 seconds) following identification of a SAR Grade 2 or higher and confirmation of enrollment by the Principal Investigator. The second inhalation will be administered approximately 10 seconds later, and the subject will be observed for approximately 2 minutes for signs of symptom resolution.\n\nInhalations will continue in this manner until either:\n\n1. resolution of systemic symptoms (defined as a reduction in SAR Grade to ≤1), or\n2. if maximum number of inhalations (8 inhalations) has not been reached, complete resolution of systemic symptoms (defined as reduction in SAR Grade to 0) without exceeding maximum 8 inhalations, or\n3. administration of intra-muscular epinephrine, whichever occurs earlier.\n\nIf a recurrence of symptoms is observed, administration may continue until a maximum of 8 inhalations is reached.",[13],"Drug: Inhaled Epinephrine",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","0.125 mg per inhalation.\n\nThe maximum proposed dose to be administered is 1.0 mg (consisting of 8 inhalations of 0.125 mg over 6 minutes).",[9],null,[21],{"name":22,"affiliation":5,"role":23},"George H. Luciuk, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","1-604-270-7801","gh.luciuk@dr.com",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Richmond","British Columbia","V7C 5L9","Canada","CA",{"type":38,"coordinates":39},"Point",[40,41],-123.13683,49.17003,{"lat":41,"lon":40},[44,45],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Dr. George Luciuk","President, Chief Medical Officer","100595922","phase-1-effects-of-inhaled-epinephrine-on-systemic-allergic-reactions-during-allergy-testing-immunotherapy-or-oral-challenges-100595922",false,"NCT07038746","Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges","A Phase 1b, Open-Label, Exploratory Study Evaluating the Effects of Inhaled Epinephrine in Individuals Experiencing Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges","Inclusion Criteria:\n\n1. 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).\n2. Have undergone either a) allergy testing for suspected sensitivity\u002Fallergy, b) future oral challenge (food and\u002For 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\u002For drug) for future OIT, and deemed eligible for enrollment by the Principal Investigator.\n3. For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception\\* method between Screening and End-of-Study Visits.\n\nExclusion Criteria:\n\n1. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.\n2. Known history or presence of clinically disease\u002Fcondition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.\n3. Abnormal vital signs at screening (i.e., systolic blood pressure: \\\u003C 90 or \\>140 mmHg, diastolic blood pressure: \\\u003C 40 or \\> 90 mmHg or, heart rate: \\\u003C 45 or \\> 100 bpm), respiration rate \\\u003C 8 or \\> 20 resp.\u002Fmin.\n4. Females who are pregnant, plan to become pregnant or lactating.\n5. Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current\u002Fplanned participation in another interventional study during this study.\n6. Previous treatment in this study.\n7. Any other reason that, in the opinion of the Investigator, is likely to unfavorably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.","ALL","12 Years",{"count":60,"type":61},100,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","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\u002For drug) or oral immunotherapy (OIT).",[67,68],"Hypersensitivity","Anaphylaxis",[70,71,72,73,67,74,68,75,76,77,78],"Immunotherapy","Epinephrine","Upper airway laryngeal edema","Upper airway pharyngeal edema","Hypersensitivity, immediate","Vasoconstrictor agents","Adrenergic alpha-Agonists","Adrenergic beta-Agonists","Bronchodilator agents","2026-02-03",{"date":81,"type":82},"2026-02-05","ACTUAL",{"date":84,"type":82},"2025-08-25",{"date":86,"type":61},"2026-07",{"name":48,"class":6},1]