[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allergic-reactions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allergic-reactions":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100580197","phase-4-study-evaluating-the-safety-and-efficacy-of-neffy-or-intramuscular-adrenalin-in-patients-with-allergic-reactions-after-oral-food-challenge-or-allergen-immunotherapy-100580197",false,"NCT06834165","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","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.","ALL","4 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","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.",[26],"Allergic Reactions","RECRUITING","2026-04-20",{"date":30,"type":31},"2026-04-21","ACTUAL",{"date":33,"type":31},"2025-05-20",{"date":35,"type":20},"2027-06",{"name":37,"class":38},"ARS Pharmaceuticals, Inc.","INDUSTRY",6,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100608005","determination-of-blomia-tropicalis-allergen-extract-in-prick-test-units-100608005","NCT07195929","Determination of Blomia Tropicalis Allergen Extract in Prick Test Units","Blomia Tropicalis Allergen Extract. Determination of the Vivo Histamine Equivalent Prick Test Units","Inclusion Criteria:\n\n1. Female or male aged 18 to 64 years, both included.\n2. Subjects who have signed and dated the informed consent form.\n3. Subjects must reside in a geographical area where allergic problems caused by Blomia tropicalis are relevant.\n4. Positive medical history of inhalant allergy (rhinitis and\u002For rhinoconjunctivitis and\u002For asthma) to Blomia tropicalis\n5. A positive prick-test (mean wheal diameter ≥ 3 mm) with an extract of the same allergen and\u002For presence of specific IgE against complete extract or any molecular component to the allergenic source.\n6. The area of the wheal obtained with 10 mg\u002FmL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm.\n7. The area of the wheal obtained with negative control should be \\\u003C 7 mm², which corresponds to a mean wheal diameter \\\u003C 3 mm.\n8. Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period.\n9. Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal; contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.\n\nExclusion Criteria:\n\n1. Subjects outside the age range.\n2. Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Blomia tropicalis extract.\n3. Subjects with significant symptoms of rhinoconjunctivitis and\u002For bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.\n4. Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests.\n5. Subjects on treatment with ß-blockers.\n6. Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) (See Section 5.2).\n7. Clinically unstable subjects (acute asthma, febrile, etc.).\n8. Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).\n9. Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed.\n10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).\n11. States in which the subject is unable to offer cooperation and severe psychiatric disorders.\n12. Pregnant or potentially pregnant women and breastfeeding women.\n13. Subjects with known phenol allergy.","18 Years","64 Years",{"count":50,"type":20},30,[52],"NA","The primary objective is to assess the concentration of Blomia tropicalis allergenic extract that induces a wheal of size equivalent to that produced by a 10 mg\u002FmL histamine dihydrochloride solution, in order to be used as in-house reference preparation (IHRP).",[26,55],"Allergic Skin Reaction",[57,58,59,60],"Allergy","In-House Reference Preparation (IHRP)","Prick test","Blomia tropicalis","NOT_YET_RECRUITING","2025-09-29",{"date":64,"type":31},"2025-10-02",{"date":66,"type":20},"2025-11",{"date":68,"type":20},"2027-01",{"name":70,"class":38},"Inmunotek S.L.",1]