[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654602":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":44,"armGroups":52,"interventions":59,"overallOfficials":65,"centralContacts":73,"locations":83,"responsibleParty":101,"collaborators":44,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":44,"studyType":117,"phases":118,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":134,"whyStopped":44,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Change in inhaler technique errors","Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.","Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)",[14,18,21,24,27,30,34,37,40],{"measure":15,"description":16,"timeFrame":17},"Asthma Control Test (ACT)","childrens ACT score change over time","Baseline vs. week 12",{"measure":19,"description":20,"timeFrame":17},"Change in FEV1\u002FFVC ratio","Change in FEV1\u002FFVC ratio (%) from baseline to 3 months.",{"measure":22,"description":23,"timeFrame":17},"Change in FEF25-75","Change in FEF25-75 (L\u002Fs) from baseline to 3 months.",{"measure":25,"description":26,"timeFrame":17},"Change in FEF75","Change in FEF75 (L\u002Fs) from baseline to 3 months.",{"measure":28,"description":29,"timeFrame":17},"Fractional exhaled nitric oxide (FeNO)","Change in FeNO",{"measure":31,"description":32,"timeFrame":33},"Proportion of prescribed inhalations taken","Adherence to inhaled medication measured as the percentage of prescribed inhalations taken over the 3-month study period.","3 months (from baseline to final study visit)",{"measure":35,"description":36,"timeFrame":33},"Asthma exacerbations","Number of asthma exacerbations during 3 months",{"measure":38,"description":39,"timeFrame":33},"Short-acting β-agonist (SABA) use","Number of SABA puffs measured by device data",{"measure":41,"description":42,"timeFrame":43},"System Usability Scale (SUS)","SUS score about the Aflo™ device","SUS score measured once at week 12 (final study visit)",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE","Asthma management in children is often limited by inadequate inhaler technique and adherence. The aflo™ Smart Spacer is a CE-marked device that measures both adherence and inhaler technique, providing real-time feedback, medication reminders, and symptom tracking.\n\nThis single-arm, single-center, 12-week pilot study aims to assess the platform's potential effect on inhaler technique errors, its feasibility in pediatric clinical practice, and usability. Participants will use the device for 3 months in daily life, with assessments at baseline and week 12, and phone calls at weeks 4 and 8. Findings will inform the design and sample size of a future controlled clinical trial.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Aflo™ Smart Spacer Platform","EXPERIMENTAL","Participants receive the aflo™ device for home use during 3 months.",[58],"Device: Aflo™ Smart Spacer",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":44},"DEVICE","Aflo™ Smart Spacer","A CE-marked digital spacer device that measures inhaler technique (step-by-step), adherence, daily symptoms, and provides real-time feedback and reminders via a linked mobile application.",[54],[66,70],{"name":67,"affiliation":68,"role":69},"Job FM van Boven, Dr","Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":72,"role":69},"Annelies M Zwitserloot, Dr","Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":44,"email":78},"Job F.M. van Boven, Dr","CONTACT","003150 361 7893","j.f.m.van.boven@umcg.nl",{"name":80,"role":76,"phone":81,"phoneExt":44,"email":82},"Sophie I.M. Veenstra, MSc","0031646938143","s.i.m.veenstra@umcg.nl",[84],{"facility":85,"status":44,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"UMC Groningen","Groningen","Provincie Groningen","9713 GZ","Netherlands","NL",{"type":92,"coordinates":93},"Point",[94,95],6.56667,53.21917,{"lat":95,"lon":94},[98,100],{"name":99,"role":76,"phone":81,"phoneExt":44,"email":82},"Sophie I.M. Veenstra, Msc",{"name":75,"role":76,"phone":77,"phoneExt":44,"email":78},{"type":102,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100654602","using-a-digital-spacer-for-inhaler-technique-education-in-pediatric-asthma-100654602",false,"NCT07803042","Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma","Using the Aflo™ Digital Smart Spacer Platform to Improve Inhaler Technique in Children With Uncontrolled Asthma: A Prospective Pilot Study - INSPIRE-KIDS (INhaler SPacer Improvement & Real-time Education - KIDS)","INSPIRE-KIDS","Inclusion Criteria:\n\n* Age 6-18 years\n* Physician-diagnosed asthma\n* Using ICS ± LABA ± LAMA ± SABA via pMDI and spacer suitable for aflo™\n* Uncontrolled asthma (ACT \\\u003C19 and\u002For recent exacerbation and\u002For suspected nonadherence\u002Fpoor technique)\n* Access to an Apple or Android smartphone (OS ≥ 4.3)\n* Willing and able to give assent\u002Fconsent (parents\u002Fguardians for minors)\n\nExclusion Criteria:\n\n* Chronic lung disease other than asthma\n* Significant cardiac disease\n* Not able to understand Dutch sufficiently\n* No access to stable mobile internet","ALL","6 Years","18 Years",{"count":115,"type":116},12,"ESTIMATED","INTERVENTIONAL",[46],"This pilot study evaluates the feasibility, usability, and potential effect of the aflo™ Smart Spacer platform in children aged 6-18 with uncontrolled asthma using pMDIs and spacers. The study investigates changes in inhaler technique, asthma control, and lung function following 3 months of daily use of the CE-marked aflo™ device.",[121,122,123],"Asthma (Diagnosis)","Inhaler Technique","Pediatric Asthma",[125,126,127,128,129,130,131,132,133],"pediatric asthma","inhaler technique","medication adherence","pMDI","spacer","smart inhaler","smart spacer","digital health","aflo™","NOT_YET_RECRUITING","2026-08-31",{"date":137,"type":138},"2026-09-03","ACTUAL",{"date":140,"type":116},"2026-09",{"date":142,"type":116},"2027-06",{"name":5,"class":6},1]