[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Copenhagen Studies on Asthma in Childhood\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100656318","a-randomized-controlled-trial-of-oral-immunotherapy-versus-allergen-avoidance-in-children-under-2-years-with-food-allergy-100656318",false,"NCT07825662","A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy","A Systems Biology Approach to Treatment of Food Allergy: A Randomized Controlled Trial of Oral Immunotherapy in Children Under 2 Years (SAFARI)","SAFARI","Inclusion Criteria:\n\n* Children age 0-2 years\n* Diagnosed IgE-mediated food allergy to tree-nuts, sesame, and\u002For peanuts, defined as: Positive oral food challenge (OFC) at inclusion or within 6 months before AND positive SPT (≥ 3 mm) or specific IgE (≥ 0.35 kUA\u002FL)\n* Both parents provide informed consent\n\nExclusion Criteria:\n\n* Already undergoing any form of immunotherapy\n* Already undergoing any form of biological treatment\n* Medical conditions precluding OITs: Uncontrolled asthma, atopic dermatitis requiring systemic therapy, eosinophilic esophagitis (EoE) and other GI-diseases, other severe immunological diseases (e.g. inborn errors of immunity )","ALL","24 Months",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether oral immunotherapy (OIT) is safe and effective for treating food allergy in children aged 0-2 years with peanut, tree nut, or sesame allergy. The study also aims to identify biological mechanisms and biomarkers associated with natural tolerance development and successful OIT using a systems biology approach.\n\nThe main questions it aims to answer are:\n\n1. Does oral immunotherapy increase the likelihood of successful desensitization and sustained unresponsiveness compared with allergen avoidance?\n2. Can immune, microbiome, metabolomic, genetic, and epigenetic profiles predict treatment response, natural tolerance development, and long-term outcomes?\n\nResearchers will compare children receiving oral immunotherapy with children receiving standard care (allergen avoidance) to determine differences in treatment success, sustained unresponsiveness, safety, quality of life, and biological markers.\n\nParticipants will:\n\n* Be randomized to either oral immunotherapy or allergen avoidance for 18-24 months.\n* Undergo oral food challenges at study visits to assess allergic reactivity and treatment outcomes.\n* Provide blood, urine, hair, skin swabs, skin tape strips, throat swabs, nasal lining fluid, and stool samples at baseline and at the end of the study for immune, microbiome, metabolomic, gene expression, and epigenetic analyses.\n* Complete allergy assessments, including skin prick testing and clinical evaluations.\n* Have allergic symptoms, adverse reactions, and development of other allergic diseases monitored throughout the study.\n* Have parents complete questionnaires assessing food allergy-related quality of life, anxiety, and coping.",[27,28],"Food Allergy in Children","Oral Immunotherapy for Food Allergy",[30,31,32,33,34,35,36,37,38,39],"Food allergy","Oral immunotherapy","Children","Peanut Hypersensitivity","Sesame Hypersensitivity","Treenut Hypersensitivity","Immunotherapy","Peanut allergy","Sesame allergy","Tree nut allergy","NOT_YET_RECRUITING","2026-09-11",{"date":43,"type":44},"2026-09-17","ACTUAL",{"date":46,"type":21},"2026-09",{"date":48,"type":21},"2031-06",{"name":50,"class":51},"Copenhagen Studies on Asthma in Childhood","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":52},"100442571","phase-2-high-dose-vitamin-d-supplement-for-the-prevention-of-acute-asthma-like-symptoms-in-preschool-children-100442571","NCT05043116","High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children","High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children - a Double-blind, Randomized, Controlled Trial","COPSACvitd","Inclusion Criteria:\n\nThe study population consists of children in the age group 1-5 years admitted to a pediatric ward, due to an acute episode with asthma-like symptoms. An acute asthma-like episode will be defined as annoying coughing, wheezing (wheezing or wheezing in connection with exhalation) and \u002F or dyspnoea, which affects the child's well-being and requires hospitalization in a pediatric ward. Participation in the study requires that the child is in or has been in treatment with SABA, as monotherapy, or in combination with ICS, and possibly also in combination with LTRA in accordance with the Danish guidelines\n\nExclusion Criteria:\n\n* The child is hospitalized with pneumonia\n* The child's daily intake of vitamin D supplementation is\\> 400 IU \u002F day (\\~ 10 μg \u002F day).\n* The child is given a combination of vitamin and dietary supplements containing vitamin D, thus the daily recommended dose is exceeded, as 2400 IU \u002F day (\\~ 60 μg \u002F day) is accepted for children aged 1-4 years, as everyone here is recommended to take 400 IU \u002F day (\\~ 10 μg \u002F day) by the Danish Health and Medicines Authority.\n* The baby has been exclusively breastfed for the past 6 months.\n* The child is malnourished\n\n  * for children\\> 2 years of age whose age-specific BMI is less than the 3rd percentile.\n  * for children \\\u003C2 years, whose weight or height in relation to age is less than the 3rd percentile.\n* The child is a newly arrived refugee or immigrant from regions with a high risk of rickets.\n* The child has other chronic lung diseases.\n* The child is diagnosed with other conditions such as chronic lung disease, impaired renal function, neurological or psychiatric disorders, congenital or documented acquired QT prolongation, clinically relevant bradycardia, cardiac arrhythmia or severe heart failure and \u002F or hepatic impairment.\n* The child is being treated with medication that alters calcium or vitamin D absorption \u002F metabolism.","12 Months","71 Months",{"count":64,"type":21},320,[66],"PHASE2","To investigate whether high-dose vitamin D supplementation may have a beneficial effect on secondary prevention in preschool children (1-5 years of age), with respiratory infections being the primary cause of acute exacerbations with asthma-like symptoms.",[69],"Asthma in Children",[71,72,73],"Wheeze","Infections","Vitamin D","RECRUITING","2025-04-11",{"date":77,"type":44},"2025-04-16",{"date":79,"type":44},"2022-10-01",{"date":81,"type":21},"2031-10-01",{"name":50,"class":51},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":52},"100441422","phase-2-azithromycin-treatment-of-hospitalized-children-with-asthmatic-symptoms-100441422","NCT05028153","Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms","Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study","COPSACazt","Inclusion Criteria:\n\n* Previous episode(s) with asthma-like symptoms and \u002F medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.\n* The parent\u002Fguardian(s) agrees to admit the child and is willing to follow the procedure of the trial.\n* The child is between 12-71 months old.\n* Fluent Danish skills with parents \u002F guardians.\n\nExclusion Criteria:\n\n* Known allergy to macrolide antibiotics.\n* Known impaired liver function.\n* Known renal impairment.\n* Known with neurological or psychiatric diseases.\n* Known with congenital or documented acquired QT interval.\n* Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.\n* Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)\\> 50 and \u002F or Fever: temperature\\> 39 °C and \u002F or C-reactive protein (CRP)\\> 50).",{"count":64,"type":21},[66],"The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.",[95],"Childhood Asthma With Acute Exacerbation",[97,72,71,98],"Asthma","Antibiotics","2025-04-09",{"date":101,"type":44},"2025-04-13",{"date":103,"type":44},"2022-11-14",{"date":105,"type":21},"2032-11-13",{"name":50,"class":51},""]