[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441422":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":61,"studyPopulation":49,"armGroups":62,"interventions":75,"overallOfficials":85,"centralContacts":90,"locations":100,"responsibleParty":120,"collaborators":49,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":49,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":103,"whyStopped":49,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Copenhagen Studies on Asthma in Childhood","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Duration in days of the asthma-like episode from the start of randomization.","Number of days based on a diary.","1-30 days",[14,18,22,25,28,30,32,35,37,40,43,46],{"measure":15,"description":16,"timeFrame":17},"Change in symptom score.","Using a previously validated symptom scoring model based on a diary. The score range is from 0 (no symptoms) and up to 3 (depending on presence of one or more of the followings symptoms: Cough, breathlessness and wheezing).","From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.",{"measure":19,"description":20,"timeFrame":21},"Effect modification in relation to the child's respiratory microbiota profile.","Airway microbiota, pathogenic bacteria and vira as measured by 16S-rRNA and whole genome sequencing.","Sample time, day 1",{"measure":23,"description":24,"timeFrame":21},"Effect modification in relation to the child's respiratory immunological profile.","Evaluation of immune mediator profiles (cytokine and chemokine levels) in the upper airway epithelial lining fluid.",{"measure":26,"description":27,"timeFrame":12},"The length of hospitalization (days)","Determined by participants medical record.",{"measure":29,"description":11,"timeFrame":12},"Need for SABA during the asthma-like episode",{"measure":31,"description":11,"timeFrame":12},"Need for oral corticosteroids (OCS) during the asthma-like episode.",{"measure":33,"description":34,"timeFrame":21},"Stratification of the above analyzes.","On the basis of the presence or absence of bacteria\u002Fmicrobiota in the respiratory tract, based on outcomes 3, 4 and 5.",{"measure":36,"description":11,"timeFrame":12},"Number of days away from daycare offers.",{"measure":38,"description":39,"timeFrame":12},"Health economic gain based on treatment costs and lost earnings. lost earnings for parent \u002F guardian (s)","The number of days home from daycare causing parent absenteeism due to illness based on this diary registration.",{"measure":41,"description":42,"timeFrame":12},"Gut microbiome profile","Occurrence, diversity and abundance of gut microbiota using 16S rRNA sequencing and whole genome sequencing.",{"measure":44,"description":45,"timeFrame":12},"Resistance profiles","Occurrence, diversity and abundance of antibiotic resistance genes as assessed by metagenome sequencing.",{"measure":47,"description":48,"timeFrame":12},"Adverse Event (AE) registration","Number of events and type of event based on a diary.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":55,"maskingDescription":49,"whoMasked":56},"QUADRUPLE",[57,58,59,60],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently \u002F have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and \u002F or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.\n\nThe study hypothesis is:\n\n● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently \u002F have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Antibiotics","ACTIVE_COMPARATOR","Azithromycin (10mg\u002Fkg) administered via oral suspension for 3 consecutive days",[68],"Drug: Azithromycin Oral Liquid Product",{"label":70,"type":71,"description":72,"interventionNames":73},"Placebo","PLACEBO_COMPARATOR","Placebo with no active substance administered via oral suspension for 3 consecutive days",[74],"Other: Placebo mixture",[76,81],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":49},"DRUG","Azithromycin Oral Liquid Product","10 mg\u002Fkg for 3 consecutive days",[64],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":49},"Placebo mixture","Placebo mixture containing no active substance",[70],[86],{"name":87,"affiliation":88,"role":89},"Jakob Stokholm, MD, PhD","University Hospital of Copenhagen, DK-2820 Gentofte, Denmark","PRINCIPAL_INVESTIGATOR",[91,96],{"name":92,"role":93,"phone":94,"phoneExt":49,"email":95},"Klaus Bønnelykke, MD, PhD","CONTACT","+4538677360","kb@copsac.com",{"name":97,"role":93,"phone":98,"phoneExt":49,"email":99},"Ulrik Ralfkiaer, MSc, PhD","+4538674164","administration@dbac.dk",[101],{"facility":102,"status":103,"city":104,"state":49,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"University Hospital of Copenhagen","RECRUITING","Gentofte Municipality","2820","Denmark","DK",{"type":109,"coordinates":110},"Point",[111,112],12.54601,55.74903,{"lat":112,"lon":111},[115,117,119],{"name":92,"role":93,"phone":116,"phoneExt":49,"email":95},"+45 3867 7360",{"name":97,"role":93,"phone":118,"phoneExt":49,"email":99},"+45 3867 4164",{"name":87,"role":89,"phone":49,"phoneExt":49,"email":49},{"type":121,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100441422","phase-2-azithromycin-treatment-of-hospitalized-children-with-asthmatic-symptoms-100441422",false,"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).","ALL","12 Months","71 Months",{"count":134,"type":135},320,"ESTIMATED","INTERVENTIONAL",[138],"PHASE2","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.",[141],"Childhood Asthma With Acute Exacerbation",[143,144,145,64],"Asthma","Infections","Wheeze","2025-04-09",{"date":148,"type":149},"2025-04-13","ACTUAL",{"date":151,"type":149},"2022-11-14",{"date":153,"type":135},"2032-11-13",{"name":5,"class":6},1]