[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06834165":3,"trial-entities:NCT06834165":142,"trial-summary:NCT06834165":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":54,"locations":58,"central_contacts":134,"overall_officials":139,"references":140,"see_also_links":141},"NCT06834165","EPI R01","Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy","A Phase IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy","RECRUITING","2027-06","2026-04","2026-04-21","2025-05-20","ARS Pharmaceuticals, Inc.","INDUSTRY",false,"The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.",null,[19],"Allergic Reactions",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},600,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Neffy","Epinephrine nasal spray",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Adrenaline","Epinephrine injection",[38],"IM adrenaline",[40],{"measure":41,"timeFrame":42},"AEs after epinephrine treatment within 2 hours","2 hours",[],"ALL","4 Years",{"inclusion":47,"exclusion":52,"raw_text":53},[48,49,50,51],"Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.","Has body weight 15 kg or greater at the time of allergy challenge.","Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\\\u003C18 years old), assent can be obtained from his\u002Fher legal representative, and as much possible from the patient himself\u002Fherself.","Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.",[],"Inclusion Criteria:\n\n* Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.\n* Has body weight 15 kg or greater at the time of allergy challenge.\n* Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\\\u003C18 years old), assent can be obtained from his\u002Fher legal representative, and as much possible from the patient himself\u002Fherself.\n* Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.\n\nExclusion Criteria:\n\n\\- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.",[55,56,57],"CHILD","ADULT","OLDER_ADULT",[59,75,86,97,108,120],{"facility":60,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":72},"Orso Health, Inc.","La Jolla","California","92037","United States",[66,69],{"name":67,"role":68},"Investigator, MD","CONTACT",{"name":70,"role":71},"Ali Doroudchi, MD","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},32.84727,-117.2742,{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":64,"contacts":80,"geoPoint":83},"Children's National Hospital","Washington D.C.","District of Columbia","20010",[81],{"name":82,"role":68},"Ammara Ahmed, DO",{"lat":84,"lon":85},38.89511,-77.03637,{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":64,"contacts":91,"geoPoint":94},"Endeavor Health","Glenview","Illinois","60026",[92],{"name":93,"role":68},"Giselle Mosnaim, MD",{"lat":95,"lon":96},42.06975,-87.78784,{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":64,"contacts":102,"geoPoint":105},"University Of Michigan","Ann Arbor","Michigan","48105",[103],{"name":104,"role":68},"Ian Slack, MD",{"lat":106,"lon":107},42.27756,-83.74088,{"facility":109,"status":8,"city":110,"state":110,"zip":111,"country":64,"contacts":112,"geoPoint":117},"Weill Cornell Medicine\u002FNewYork Presbyterian Hospital","New York","10021",[113],{"name":114,"role":68,"phone":115,"email":116},"Miriam Samstein, M.D, Ph.D.","347-834-3746","mb.eichenbaum@gmail.com",{"lat":118,"lon":119},40.71427,-74.00597,{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":64,"contacts":125,"geoPoint":131},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[126,129],{"name":67,"role":68,"phone":127,"email":128},"513-517-1179","Yasmin.hassoun@cchmc.org",{"name":130,"role":71},"Yasmin Hassoun, MD",{"lat":132,"lon":133},39.12711,-84.51439,[135],{"name":136,"role":68,"phone":137,"email":138},"Osnat Ehrman, MSc.","952.334.5797","osnate@pacificlinkconsulting.com",[],[],[],{"nct_id":4,"conditions":143,"biomarkers":145},[144],"Allergic Reaction",[],{"nct_id":4,"found":147,"summary":148,"prompt_version":158},true,{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This interventional study plans to enroll 600 participants to compare Neffy (epinephrine nasal spray) and Adrenaline (epinephrine injection). The study phase is not specified.","completed","Study of Neffy or Adrenaline for Allergic Reactions","This study is looking at the safety of two treatments, Neffy (an epinephrine nasal spray) and Adrenaline (an epinephrine injection), for people who have allergic reactions. These reactions happen after an oral food challenge (OFC), allergen immunotherapy (AIT), or other allergy tests that might need epinephrine. The study aims to see if there are any side effects from these treatments within two hours. You could be eligible if you are at least 4 years old, weigh 15 kg (about 33 pounds) or more, and are scheduled for an allergy challenge. The study is currently unclear about its recruitment status and plans to enroll about 600 participants.","Participants will be monitored for adverse events (side effects) for 2 hours after receiving epinephrine treatment.",106,"Not specified in the trial record.","Not stated in the trial record.",[31,35],"v2"]