[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asthma-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asthma-in-children":44},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,66,100,121,145,176,198,223,251,271,292,320,344,369,399,426,446,468,489,510,529,553,590,612,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878",false,"NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"ALL","0 Years","20 Years",{"count":23,"type":24},5000,"ESTIMATED","OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","RECRUITING","2026-08-20",{"date":56,"type":57},"2026-08-21","ACTUAL",{"date":59,"type":57},"2020-03-05",{"date":61,"type":24},"2026-12",{"name":63,"class":64},"Duke University","OTHER",52,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":18,"sex":19,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100550507","the-barts-charity-childrens-environmental-health-clinic-100550507","NCT06447974","The Barts Charity Children's Environmental Health Clinic","BCCEHC","Inclusion Criteria:\n\n* Parent\u002FGuardian able to provide written informed consent\n\nReferral made by paediatric asthma team\n\nChild aged 4-17 years at the time of consent to study\n\nA diagnosis of a chronic respiratory condition (diagnosis by a medical professional)\n\nContactable for regular follow up by the research team\n\nReasonable level of English language\n\nAbility to engage with technology and devices used in the study\n\nExclusion Criteria:\n\n* Inability to use the tools and devices in the research study\n\nInability to visit the hospital for the initial hospital visit\n\nInability to allow home environmental assessment","4 Years","17 Years",{"count":76,"type":24},200,"INTERVENTIONAL",[79],"NA","The study will be based from a newly formed NHS service, the children's environmental health service. Participants will be children with a known chronic respiratory condition. Participants will undergo personal environmental exposure monitoring as well as home environmental assessments, before personalised exposure reports will be provided including a summary of their exposure and advising mitigation strategies based on exposure patterns and behaviours. The monitoring will be repeated after introduction of mitigation strategies. This will allow a comparison of the effectiveness of each method of mitigation.",[82,83,44,84],"Environmental Exposure","Health Behavior","Environmental Illness",[86,87,88,89],"asthma","Air pollution","environmental","Environmental health clinic","2026-08-11",{"date":92,"type":57},"2026-08-13",{"date":94,"type":57},"2025-07-24",{"date":96,"type":24},"2027-06",{"name":98,"class":64},"Queen Mary University of London",2,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":77,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100501842","implementation-of-asthma-community-home-and-school-management-program-asthma-champs-100501842","NCT05814510","Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)","Adult\n\nInclusion Criteria:\n\n* Aged 18 or older\n* Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS\n\nExclusion Criteria:\n\n* Unwilling to consent\n\nChildren with asthma\n\nInclusion Criteria:\n\n* Asthma diagnosis\n* Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS\n\nExclusion Criteria:\n\n* Unwilling to provide assent",{"count":107,"type":24},1000,[79],"The long-term goal is to implement an evidence-based asthma intervention based on the Center for Disease Control's recommended framework (EXHALE) within Baltimore City Public Schools (BCPS). As part of a stepped wedge pragmatic trial the investigators will:\n\n1. Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.\n2. Conduct a pragmatic trail using a stepped wedge design to evaluate implementation of a school and home asthma intervention program to reduce asthma-related absences, healthcare utilization and exacerbations and improve asthma control, among children enrolled in 32 Baltimore City elementary schools.\n3. Use qualitative methods (observation and semi structured interviews) to obtain stakeholder feedback (parents, community health workers, school personnel and administrators) on impact of Asthma CHAMPS, identify potential refinements in intervention and implementation strategies, and evaluate impact of local adaptation and fidelity on implementation success and sustainability.",[44],"2026-08-06",{"date":113,"type":57},"2026-08-10",{"date":115,"type":57},"2023-11-27",{"date":117,"type":24},"2027-06-30",{"name":119,"class":64},"Johns Hopkins University",1,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":19,"minAge":128,"maxAge":74,"enrollmentInfo":129,"targetDuration":4,"studyType":77,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":99},"100511892","mechanistic-study-of-inspiratory-training-in-childhood-asthma-mica-100511892","NCT05945355","Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)","MICA","Inclusion Criteria:\n\n* 6-17 years of age\n* Documented clinician-diagnosed asthma\n* Currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease)\n* Either obese (≥95th percentile BMI and less than 170% of the 95th CDC percentile) or have a normal BMI (BMI 5th to 84th CDC percentile)\n\nExclusion Criteria:\n\n* ACT (asthma control test) score \\\u003C17\n* Ever intubated for asthma\n* FEV1 \\\u003C 50% of predicted at enrollment\n* Currently pregnant\n* Legal guardian unable to consent in English or Spanish\n* Any major chronic illness that, in the opinion of the PI, would interfere with participation\n* Younger than 6 years of age","6 Years",{"count":130,"type":24},76,[79],"This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male\u002Ffemale), race\u002Fethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status",[44,134,135,136],"Obesity","Pediatric Obesity","Pediatric Asthma","2026-08-03",{"date":139,"type":57},"2026-08-05",{"date":141,"type":57},"2024-08-01",{"date":143,"type":24},"2027-10-30",{"name":63,"class":64},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":19,"minAge":153,"maxAge":74,"enrollmentInfo":154,"targetDuration":4,"studyType":77,"phases":156,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":172,"leadSponsor":174,"locationsCount":120},"100650387","smart-inhaler-and-remote-asthma-management-in-adolescents-with-intellectual-and-developmental-disabilities-100650387","NCT07746921","Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities","A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler Cap to Support for Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities","IDD","Inclusion Criteria:\n\n* Adolescents ages 10-17 years\n* Diagnosis of mild-to-moderate intellectual disability (ID) ICD-10: F70-F71 and\u002For diagnosis of developmental disability, including autism: ICD-10: F80-89; (Diagnosis of ID and\u002For autism in the EMR may be used to reach out to potential families).\n* Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma or diagnosis indicated in the EMR: ICD-10: J45.40-J45.909; (Diagnosis of ID and\u002For autism in the EMR may be used to reach out to potential families).\n* Parent\u002Flegal guardian has a smartphone and is willing to download an application associated with the CapMedic device, is assigned to the intervention group.\n* Parent\u002Flegal guardian is willing to answer questions about their child.\n* Parent\u002Flegal guardian and adolescent must have the ability to understand study procedures and to comply with them for the entire length of the study\n* English or Spanish-speaking participants\n* Not currently involved in other studies using digital inhalers\n* Males and females of reproductive capability will be enrolled: contraception is not necessary or required.\n* Participants must use any of the following MDIs (as indicated by the 510(k) as maintenance inhaled corticosteroids (ICS): Advair HFA, Flovent HFA, Symbicort HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.\n\nExclusion Criteria:\n\n* Health status or any clinical conditions: limited life expectancy and complex respiratory pathologies (e.g., tracheostomy, restrictive lung disease, bronchopulmonary dysplasia, cystic fibrosis) to prevent confounding in asthma treatment outcomes.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.","10 Years",{"count":155,"type":24},34,[79],"Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population for remote home use. This study aims to investigate whether daily application of smart inhalers (1) is feasible, acceptable and usable in the IDD population for remote asthma management, (2) improves the rate of medication use and correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population for remote home use.",[44,159,160,161],"Intellectual Disabilities (F70-F79)","Developmental Disability","Autism Spectrum Disorder",[163,86,164,165,166,167],"smart inhaler","remote home management","medication adherence","intellectual disability","developmental disability","NOT_YET_RECRUITING","2026-07-30",{"date":139,"type":57},{"date":113,"type":24},{"date":173,"type":24},"2027-08-09",{"name":175,"class":64},"Children's Hospital Los Angeles",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":19,"minAge":73,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":77,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":120},"100649491","artificially-intelligent-robot-control-100649491","NCT07738016","Artificially Intelligent Robot Control","Asthma Under Artificially Intelligent Robot (AIR) Control: Robotic Support for Pediatric Education","AIR","Inclusion Criteria for Caregivers or Parents:\n\n* The participant must be at least 18 years old.\n* The participant must be willing and able to participate.\n* The participant can read English or Spanish and is able to fill out survey instruments by themselves or with assistance.\n* The participant cares for a child age 4-11 with asthma.\n\nInclusion Criteria for Children:\n\n* The participant must be at least 4 years old - 11 years old with asthma.\n* The child can speak English or Spanish.\n* The participant must assent to participation.\n* The participant's guardian must have consented.\n\nExclusion Criteria for Caregivers or Parents:\n\n* The participant is younger than 18 years old.\n* The participant is unwilling to participate in the study.\n* The participant is unable to complete survey instruments.\n* The participant does not care for a child with asthma who is age 4-11.\n\nExclusion Criteria for Children:\n\n* The participant is younger than 4 years old, over 11 years old, or does not have asthma.\n* The child does not speak English or Spanish.\n* The participant is unwilling to participate in the study.\n* The participant's guardian did not consent.",{"count":185,"type":24},80,[79],"The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.",[44,189,190],"Artificial Intelligence","Caregiver Burden",{"date":137,"type":57},{"date":193,"type":24},"2026-09",{"date":195,"type":24},"2027-08-30",{"name":197,"class":64},"University of Miami",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":74,"enrollmentInfo":206,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":120},"100610820","biomarkers-and-respiratory-omics-as-new-children-opportunities---study-of-clinical-outcomes-and-predictivity-evaluation-100610820","NCT07232550","Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation","Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation - a Multi-cohort, Multi-center Study","BRONCHOSCOPE","Inclusion Criteria:\n\n* Age at the beginning of the study 0-17 years old\n* Clinical indication and qualification by the attending physician for fiberoptic bronchoscopy under general anesthesia:\n\n  * Obstruction of the airways:\n  * Suspicion of foreign body aspiration\n  * Persistent stridor\n  * Abnormal result of functional tests of respiratory system - flattening of inspiratory or expiratory curve, presence of restriction (tested vital capacity \\\u003C5 percentile) or irreversible obstruction (persistence of Tiffneau index \\\u003C5 percentile despite administration of bronchodilators)\n  * Radiological findings located in the course of the larynx, trachea or bronchi\n  * Persistent atelectasis on subsequent radiological examinations\n  * Persistent cough \\>4 weeks\n  * Hemoptysis\n  * Suspected laryngomalacia or tracheobronchomalacia\n  * Suspected tracheoesophageal fistula\n  * Persistent dyspnea unresponsive to anti-asthmatic treatment used for min. 2 months, with no other identifiable causes\n  * Radiologically detected mediastinal abnormalities\n  * Suspected presence of a vascular ring\n  * Presence of excessive secretions that are impossible for the patient to expectorate\n  * Fine needle biopsy of cystic lesions\n* Obtained consent from patient\u002Flegal guardian for participation in the study\n\nExclusion Criteria:\n\n* Active acute respiratory infection up to 4 weeks before the procedure\n* Taking antibiotics or systemic glucocorticosteroids up to 4 weeks before the procedure\n* Patients with very severe comorbidities (congenital immunodeficiencies, genetic disorders, neurological or neuromuscular diseases, cancer, severe congenital heart defects, heart failure, liver failure, inflammatory bowel disease, celiac disease)\n* Patients with blood clotting disorders\n* Children with diagnosed respiratory diseases other than asthma and protracted bacterial bronchitis - including interstitial diseases, tuberculosis, inflammation of small and medium-sized blood vessels\n* Patients for whom \\>48 hours have passed between suspicion of foreign body aspiration and interventional bronchoscopy\n* Children with foreign body aspiration having a foreign body located in the trachea",{"count":207,"type":24},160,"The goal of this observational study is to improve the identification of biomarkers that predict disease progression and to assess the effectiveness of current therapies in children with asthma and protracted bacterial bronchitis.\n\nThe main aim of the study is to evaluate the microbiome composition and diversity, cellular composition, and metabolomic profile. In addition, to assess their correlation on subsequent treatment and disease course in children with asthma, protracted bacterial bronchitis, and in those receiving inhaled glucocorticosteroids without a diagnosis of asthma.\n\nParticipants will undergo fiberoptic bronchoscopy. During bronchoscopy, the performing physician will collect Bronchoalveolar lavage fluid samples for metagenomic and metabolomic analysis, as well as mucosal biopsies for histopathological evaluation.",[44,210,211],"Protracted Bacterial Bronchitis","Chronic Cough",[213,214],"PBB","Asthma","2026-07-28",{"date":169,"type":57},{"date":218,"type":57},"2026-03-06",{"date":220,"type":24},"2035-12",{"name":222,"class":64},"Medical University of Warsaw",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":19,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":120},"100531568","prospective-multicentre-study-on-symptoms-in-first-onset-bronchial-asthma-in-children-and-adolescents-100531568","NCT06201494","Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents","Inclusion Criteria:\n\n\\- Child 3 - 18 years old, first evaluation in pulmonary outpatient clinic for any of the following respiratory symptoms: cough, shortness of breath, chest tightness, wheezing, recurrent lower respiratory tract and lung infections, dyspnoea of any type, pathological listening findings.\n\nExclusion Criteria:\n\n* Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.","3 Years","18 Years",{"count":185,"type":24},"Bronchial asthma may present with symptoms other than the commonly reported complaints (cough, chest tightness, shortness of breath and wheezing). Less common symptoms include chronic or recurrent productive cough, inspiratory dyspnoea or recurrent pneumonia. Children presenting with these symptoms are often diagnosed with asthma bronchiale and benefit from antiasthmatic management.",[214,44,234,235,41,236,237,238,239,240,241],"Dyspnea","Cough","Wheezing","Shortness of Breath","Chest Tightness","Lower Respiratory Tract and Lung Infections","Recurrent Respiratory Tract Infections","Mucus; Plug","2026-07-13",{"date":244,"type":57},"2026-07-14",{"date":246,"type":57},"2023-01-01",{"date":248,"type":24},"2027-06-01",{"name":250,"class":64},"Charles University, Czech Republic",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":19,"minAge":230,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":99},"100439624","y-of-central-maryland-head-start-asthma-implementation-100439624","NCT05004714","Y of Central Maryland Head Start Asthma Implementation","Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers","Aim 1\n\nInclusion Criteria:\n\n* Aged 18 or older\n* Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma\n* Cognitive ability to provide consent\n* Willing to be audio recorded",{"count":259,"type":24},500,"Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Head Start (HS) serves over one million low income children in the US each year by focusing on early learning, physical health, and family engagement. HS is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. We have demonstrated the effectiveness of a multi-level staff and family education program (ABC Asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. However, these interventions are not successfully integrated within community organizations for long-term sustainability. It is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. Implementation strategies are frequently developed atheoretically and may not be tailored to the setting. The overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with Head Start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of ABC Asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. The YMCA of Central Maryland have enthusiastically agreed to implement the Maryland ABC HS Asthma within 40 sites in four communities: Baltimore City, Baltimore County, Anne Arundel County, and Prince George's County.",[44,262,263],"Implementation","Preschool Children","2026-07-10",{"date":242,"type":57},{"date":267,"type":57},"2020-08-01",{"date":269,"type":24},"2027-07-31",{"name":119,"class":64},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":19,"minAge":278,"maxAge":230,"enrollmentInfo":279,"targetDuration":4,"studyType":77,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":120},"100528312","smarthome-feasibility-trial-100528312","NCT06159127","SMART@Home Feasibility Trial","Self-Management Assistance for Recommended Treatment (SMART)@Home Care","Inclusion Criteria:\n\n* Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma\n* Ages 12-18\n* English fluency for patient and caregiver\n\nExclusion Criteria:\n\n* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review","12 Years",{"count":7,"type":24},[79],"The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.\n\nResults from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.\n\nA beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.",[214,44],[214],"2026-06-30",{"date":286,"type":57},"2026-07-02",{"date":288,"type":57},"2024-09-09",{"date":269,"type":24},{"name":291,"class":64},"Children's Hospital Medical Center, Cincinnati",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":19,"minAge":73,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":77,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":120},"100557530","project-asthma---aligning-with-schools-to-help-manage-asthma-and-improve-outcomes-100557530","NCT06539312","Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes","Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities","Inclusion Criteria:\n\n* uncontrolled asthma\n\nExclusion Criteria:\n\n* other chronic lung disease such as cystic fibrosis","13 Years",{"count":301,"type":24},400,[79],"Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.",[44,305],"Directly Observed Therapy",[214,307,308,309,310,305],"Children","School-based health center","NIH Guideline-based care","Controller medication","2026-06-22",{"date":313,"type":57},"2026-06-25",{"date":315,"type":57},"2024-09-27",{"date":317,"type":24},"2028-04-30",{"name":319,"class":64},"State University of New York at Buffalo",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":19,"minAge":327,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":77,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":120},"100642714","scaling-up-the-integrated-care-pathway-for-acute-asthma-to-all-osakidetza-pediatric-services-through-a-cluster-randomized-smart-design-100642714","NCT07642388","Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design","Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized Sequential, Multiple Assignment, Randomized Trial (SMART) Design","Eligibility for healthcare settings:\n\n\\- All Pediatric Services (Primary Care n=108 and Hospital Care n=9) from 11 of the 13 Osakidetza Integrated Healthcare Organizations that are not currently implementing the ASMAbat Pathway.\n\nEligibility for professionals:\n\n* Primary Care pediatricians and nurses\n* Pediatricians and nurses in the Pediatric Emergency Department\n* Pediatricians and nurses on the inpatient ward\n* Pediatric Intensive Care pediatricians and nurses\n* Pediatric Pneumology pediatricians and nurses\n\nEligibility for patients:\n\nPatients between 2 and 14 years that have being attended between the 1st of July 2026 and the 28th of February 2029, and with an acute episode of asthma, defined as:\n\n* an episode of wheezing and a previous diagnosis of asthma or with a previous episode of wheezing\n* a first episode in a child older than 2 years with a personal\u002Ffamily history of atopy and\u002For with an objective response to bronchodilators as assessed by a severity Score","2 Years","14 Years",{"count":330,"type":24},4680,[79],"The main goal of this study is to evaluate the effectiveness of adaptive sequential implementation strategies based on facilitation in promoting the sustainable and widespread adoption and scaling up of the Integrated Care Pathway for Acute Asthma - ASMAbat across all Primary Care and Hospital Pediatric Services of Osakidetza - Basque Health Service.",[44],"2026-06-15",{"date":336,"type":57},"2026-06-16",{"date":338,"type":24},"2026-07-01",{"date":340,"type":24},"2029-02-28",{"name":342,"class":343},"Basque Health Service","OTHER_GOV",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":19,"minAge":278,"maxAge":230,"enrollmentInfo":351,"targetDuration":4,"studyType":77,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":99},"100632356","asthma-ctrl-smart-trial-100632356","NCT07512622","Asthma Ctrl SMART Trial","Improving Medication Adherence Using an Adaptive mHealth Intervention in Adolescents With Asthma.","Inclusion Criteria:\n\n* Patient age between 12-18 years\n* Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines\n* Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator\n* English fluency for patient, caregiver, and clinician\n\nExclusion Criteria:\n\n* Significant cognitive deficits that may interfere with comprehension per medical team or chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia)\n* Diagnosis of pervasive developmental disorder\n* Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, pulmonary hypertension, and moderate or severe tracheomalacia)\n* Patient receives school administered daily controller medication at the time of the enrollment visit",{"count":352,"type":24},389,[79],"The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.",[44,356],"Asthma Chronic",[358,359,86,360],"sequential, multiple assignment, randomized trial (SMART)","adherence","adolescents","2026-05-08",{"date":363,"type":57},"2026-05-11",{"date":365,"type":24},"2026-05-30",{"date":367,"type":24},"2030-06-01",{"name":291,"class":64},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":18,"sex":19,"minAge":4,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":77,"phases":379,"briefSummary":380,"conditions":381,"keywords":386,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":120},"100540001","early-life-intervention-in-pediatrics-supported-by-e-health---smoke-100540001","NCT06311162","Early Life Intervention in Pediatrics Supported by E-health - SMOKE","Early Life Intervention in Pediatrics Supported by E-health (ELIPSE II): Coaching Parents to Lower Second-hand Smoke Exposure in Children A Single-blind Randomized Controlled Parallel-group Clinical Trial","ELIPSE-II","Inclusion Criteria:\n\n* Age: younger than 6 years\n* Exposed to second-hand smoke at home (at least one parent smoking)\n* German speaking parent\n* All sex and ethnic backgrounds\n* Signed informed consent form from parent\n* Children live\u002Fgrow-up in the same household as the parental participant\n* Referred by a health care professional (e.g. physician, midwife, nurse, other professions)\n\nExclusion Criteria:\n\n* Participation in another study\u002Ftrial targeting similar outcomes\n* Participation in an active smoking cessation programme","5 Years",{"count":207,"type":24},[79],"Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .",[382,44,236,383,384,385],"Smoking Reduction","Non-Communicable Disease","Life Style","Behavior, Smoking",[387,307,388,389],"Secondhand smoke","Prevention","eHealth","2026-04-30",{"date":392,"type":57},"2026-05-06",{"date":394,"type":57},"2024-05-07",{"date":396,"type":24},"2028-12-31",{"name":398,"class":64},"Insel Gruppe AG, University Hospital Bern",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":19,"minAge":128,"maxAge":74,"enrollmentInfo":406,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":408,"conditions":409,"keywords":412,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100593819","diagnosing-asthma-with-clinically-accessible-non-invasive-and-efficient-tests-a-child-inclusive-translational-investigation-100593819","NCT07011394","Diagnosing Asthma With Clinically Accessible, Non-invasive, and Efficient Tests: a Child-inclusive Translational Investigation","DIVE 2","Inclusion Criteria:\n\n* Individuals aged 6 to \\\u003C18 years, presenting symptoms suggestive of asthma\n* Patients referred for a methacholine bronchial provocation test by primary care (defined as non-pulmonologist, non-ENT specialist, non-allergist)\n* Spirometry inconclusive\n\nExclusion Criteria:\n\n* Use of an inhaled or systemic corticosteroid in the previous 48 hours;\n* Smoking in the previous 6 hours; history of viral and\u002For bacterial respiratory infection in the past 4 weeks;\n* major cardiopulmonary disease, including: a) chronic obstructive pulmonary disease (COPD), defined by all of the following: i) aged ≥ 40 years , ii) permanent obstruction on spirometry (FEV1\u002FFVC \\\u003C0.7) and iii) a smoking history of \\>10 pack-years or known alpha-1-antitrypsin deficiency, b) lung conditions deemed significant by the investigator, including cystic fibrosis and bronchiectasis, and c) unstable heart disease.",{"count":407,"type":24},123,"Asthma is a common inflammatory respiratory disease affecting 11% of Canadians, but its diagnosis remains challenging, leading to delays in treatment or overtreatment. Spirometry with a reversibility test and bronchial provocation testing (BPT), considered the gold standard, are the reference diagnostic methods. However, access to BPT is limited as it is performed in hospital settings.\n\nType 2 inflammation biomarkers, the fractional exhaled nitric oxide (FeNO) and blood eosinophils (EOS), represent a potential alternative. In addition to their prognostic and theragnostic value, these markers predict a good response to inhaled corticosteroids in individuals aged ≥ 6 years with asthma. However, their use remains restricted to pulmonologists in specialized clinics and is not recommended as a diagnostic tool in Quebec.\n\nDespite studies demonstrating their diagnostic value in specialized settings, these tests remain underexplored in primary care and insufficiently studied in children under 12 years.\n\nThe objective of ou study is to evaluate the relevance and performance of FeNO and blood eosinophils in the diagnosis of asthma in children referred in primary care with non-diagnostic spirometry.",[410,411,44,214],"Diagnosis","Inflammation",[413,414,415,416],"observationnal study","asthma diagnosis","FeNO and eosinophil blood count","children","2026-04-29",{"date":392,"type":57},{"date":420,"type":57},"2024-04-09",{"date":422,"type":24},"2027-07-01",{"name":424,"class":64},"Université de Sherbrooke",3,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":19,"minAge":128,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":425},"100591495","propulsion-sante-inflammometry-to-improve-the-diagnostic-trajectory-in-situations-of-suspected-asthma-in-children-and-adults-100591495","NCT06981169","PROPULSION SANTE: Inflammometry to Improve the Diagnostic Trajectory in Situations of Suspected Asthma in Children and Adults","PROPULSION","Inclusion Criteria:\n\n* patients age 6 and older\n* referred by primary care ofr an asthma diagnostic test (spirometry or methacholine challenge)\n\nExclusion Criteria:\n\n* referred by pulmonologist",{"count":434,"type":24},1500,"The objective of this observational study is to assess the relevance of inflammometry (based on the measurement of fractional exhaled nitric oxide (FeNO) and blood eosinophil count (BEC)) as a tool for prioritizing respiratory diagnostic tests.\n\nThe study will evaluate the role of inflammometry (FeNO and BEC) in prioritizing diagnostic respiratory tests. It will include patients aged six and older with suspected asthma, referred by non-pulmonologists for diagnostic asthma testing (spirometry or methacholine challenge test) at three hospital centers: Sherbrooke University Hospital Center (CHUS), Sainte-Justine University Hospital Center (CHU Sainte-Justine), and the Montreal Children's Hospital.\n\nThe hypothesis is that using inflammometry as a prioritization tool would reduce diagnostic delays for high-risk patients with elevated biomarkers. This study could help shorten wait times, relieve congestion in diagnostic testing queues, and improve the diagnostic pathway. Additionally, it would enhance the interpretation of pulmonary function test results by incorporating inflammometry findings, leading to better patient stratification.\n\nPatients referred from primary care will undergo pulmonary function testing (spirometry ± methacholine challenge) and, as part of the study:\n\nFeNO measurement using a portable device Blood test for eosinophil count Questionnaire on asthma control and quality of life, completed at the visit and at follow-ups at 4, 8, and 12 months",[214,411,44],[410,214,438,439,440],"inflammation","FeNO","Blood eosinophil count",{"date":390,"type":57},{"date":443,"type":57},"2025-03-24",{"date":422,"type":24},{"name":424,"class":64},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":19,"minAge":229,"maxAge":278,"enrollmentInfo":454,"targetDuration":4,"studyType":77,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":120},"100504177","telehealth-enhanced-asthma-care-for-home-after-the-emergency-room-100504177","NCT05844891","Telehealth-Enhanced Asthma Care for Home After the Emergency Room","Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)","TEACH-ER","Inclusion Criteria (all criteria must be met):\n\n* Physician diagnosis of asthma, based on review of medical records and\u002For caregiver report.\n* Current emergency visit for an acute asthma exacerbation, requiring treatment with rescue medication.\n* Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following:\n\n  1. \\>2 days\u002Fwk with asthma symptoms in the past month,\n  2. \\>2 days\u002Fwk with rescue medication use in the past month,\n  3. \\>2 days\u002Fmonth with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or\n  4. ≥1 other episode of asthma during the past year that required systemic corticosteroids (vs. during the past 6 months if 3-4 years old).\n* Child age between ≥3 and ≤12 years.\n* Child and caregiver live in the greater Rochester, NY metropolitan area (Monroe, Wayne, Ontario, Livingston, Genesee, and Orleans Counties)\n* Emergency severity index triage scores of 2-5 (total range 1-5; scores of 1 indicate the highest acuity and likelihood of hospitalization).\n\nExclusion Criteria:\n\n* An inability to speak and understand English. Parents (and children) with low literacy \u002F health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.\n* No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan.\n* Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.\n* Children in foster care or other situations in which consent cannot be obtained from a legal guardian.",{"count":455,"type":24},430,[79],"The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom) when possible, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.",[44],"2026-04-28",{"date":461,"type":57},"2026-05-04",{"date":463,"type":57},"2024-04-01",{"date":465,"type":24},"2028-06-30",{"name":467,"class":64},"University of Rochester",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":19,"minAge":73,"maxAge":278,"enrollmentInfo":476,"targetDuration":4,"studyType":77,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":120},"100610167","promoting-asthma-management-guidelines-with-technology-based-intervention-and-care-coordination-in-clinics-and-schools-100610167","NCT07224061","Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools","Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)","PRAGMATIC-S","Inclusion Criteria:\n\n* Physician-diagnosed asthma documented in EHR\n* Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, \\>2 days\u002Fweek with symptoms, \\>2 days\u002Fweek using rescue medication, \\>2 days\u002Fmonth with nighttime symptoms, or \\>2 episodes\u002Fyear that required systemic corticosteroids\n* Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public \u002F charter \u002F private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers)\n* Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel\n* Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity\u002Fcontrol screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected.\n* Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF\n\nExclusion Criteria:\n\n* Family plans to leave school or city within 6 months\n* Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease)\n* Children in foster care or other situations in which consent cannot be obtained from a legal guardian\n* Participation in concurrent asthma intervention study\n* Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire",{"count":477,"type":24},420,[79],"The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.",[44],"2026-04-23",{"date":417,"type":57},{"date":484,"type":57},"2026-02-12",{"date":486,"type":24},"2033-06-30",{"name":488,"class":64},"Montefiore Medical Center",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":19,"minAge":377,"maxAge":278,"enrollmentInfo":495,"targetDuration":4,"studyType":77,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":509},"100516365","reducing-asthma-attacks-in-disadvantaged-school-children-with-asthma-100516365","NCT06003569","Reducing Asthma Attacks in Disadvantaged School Children With Asthma","Inclusion Criteria:\n\n* students with poor asthma control (or indicators of excess burden on school Asthma Intake Form)\n* age 5-12 years of age\n* attending one of participating schools in rural Colorado (school selection criteria: high rates of socioeconomic need based on high rates of free-and-reduced lunch or rural status)\n\nExclusion Criteria:\n\n* age \\\u003C 5 years or \\> 12 years\n* students with no or controlled asthma",{"count":496,"type":24},300,[79],"Our UH3 clinical trial, \"Reducing Asthma Attacks in Disadvantaged School Children with Asthma,\" seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \\& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our \"dissemination playbook\" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.",[44],"2026-04-06",{"date":502,"type":57},"2026-04-13",{"date":504,"type":57},"2023-09-21",{"date":506,"type":24},"2027-08",{"name":508,"class":64},"University of Colorado, Denver",13,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":19,"minAge":73,"maxAge":278,"enrollmentInfo":517,"targetDuration":4,"studyType":77,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":4},"100496487","sbat-for-health-equity-100496487","NCT05744869","SBAT for Health Equity","School-based Asthma Therapy to Advance Health Equity Among Historically Marginalized Children","Inclusion Criteria:\n\n* Physician-diagnosed asthma, with persistent symptoms or poor control based on NHLBI criteria\n* Age \\>4 and \\\u003C12 years\n* Attending school in Rochester City School District\n* Caregiver \\>18 years, and is able to understand and speak English or Spanish\n\nExclusion Criteria:\n\n* Caregiver inability to speak and understand English or Spanish. (\\*Participants unable to read will be eligible, and all instruments will be given verbally.)\n* Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.\n* In foster care or other situations in which consent cannot be obtained from a guardian.\n\nBased on our prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.",{"count":496,"type":24},[79],"The goal of this research trial is to: 1) Solidify a population health SBAT implementation strategy with our longstanding community collaborators, 2) Perform a district-wide hybrid type 3, stepped-wedge, cluster randomized trial, and 3) Assess the supportive resource utilization and essential features of SBAT to extend sustainability and fidelity in a cost-effective manner.",[44],"2026-03-19",{"date":523,"type":57},"2026-03-23",{"date":525,"type":24},"2026-08-01",{"date":527,"type":24},"2030-12-31",{"name":467,"class":64},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":19,"minAge":73,"maxAge":278,"enrollmentInfo":537,"targetDuration":4,"studyType":77,"phases":539,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":120},"100515408","hospital-to-home-study-trial-to-optimize-transitions-and-address-disparities-in-asthma-care-100515408","NCT05991115","Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care","The Hospital to Home Study: A Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care","H2H","Inclusion Criteria:\n\n1. speak English or Spanish\n2. are at least 18 years old\n3. live in the District of Columbia, Maryland, or Virginia (DMV)\n4. have a child aged 4-12 years who is hospitalized due to asthma exacerbation.\n\nExclusion Criteria:\n\n1. . Children ages 4-12 years with chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder\n2. . Children ages 4-12 years involved in interventions with behavioral component and\u002For novel asthma therapeutics will be excluded given overlap with the current intervention\n3. . Children ages 4-12 years in foster care\n4. . Families not residing in the DMV\n5. . Caregivers who do not speak English or Spanish",{"count":538,"type":24},340,[79],"Caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital. After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive the standard of care after hospital discharge. Intervention arm will receive the SOC plus an asthma navigator support after hospital discharge. Caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.",[214,44],[86,543,416],"hospitalization","2026-03-16",{"date":546,"type":57},"2026-03-17",{"date":548,"type":57},"2024-01-22",{"date":550,"type":24},"2027-07",{"name":552,"class":64},"Kavita Parikh",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":19,"minAge":128,"maxAge":74,"enrollmentInfo":560,"targetDuration":4,"studyType":77,"phases":562,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":120},"100544696","phase-2-a-clinical-trial-of-soluble-fiber-for-asthma-100544696","NCT06372249","A Clinical Trial of Soluble Fiber for Asthma","A Phase ll Randomized Controlled Trial of Soluble Fiber for Asthma","Inclusion Criteria:\n\n* Between ages 6-17\n* Asthma diagnosis within the last 2 years\n* Fractional excretion of exhaled nitric oxide (FeNO) \\> 50 ppb OR a clinical history of environmental allergies as defined by a positive skin prick or positive specific immunoglobulin E (IgE) tests to aeroallergens\n* No emergency department visits in the past 1 month\n* Ability to consume a liquid drink of fiber or placebo\n* Ability to return for a 4-6 week follow-up visit\n* No special or unique diet\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Bronchiectasis\n* Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks\n* Baseline estimated daily fiber intake less than or equal to 16 grams as determined by the ASA 24\n* Sibling of a participant already enrolled in the study",{"count":561,"type":24},105,[563],"PHASE2","Randomized controlled trial of soluble fiber (Fruitafit Inulin). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (Fruitafit Inulin) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet.",[44],[214,567,568,569,570,571,572,573,574,575,576,577,578,307,579,580],"Mild Asthma","Moderate Asthma","Severe Asthma","Allergies","Environmental Allergies","Controlled Asthma","Well-Controlled Asthma","Diet","Dietary Fiber","Dietary Supplementation","Micro-biome","Gut-microbiome","Child","Microbiome Analysis","2026-03-02",{"date":583,"type":57},"2026-03-04",{"date":585,"type":57},"2025-11-10",{"date":587,"type":24},"2027-05-31",{"name":589,"class":64},"Phoenix Children's Hospital",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":77,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":120},"100564039","the-exhale-study-treating-maternal-depression-in-an-urban-pediatric-asthma-clinic-100564039","NCT06623981","The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic","Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic","Inclusion Criteria:\n\nMaternal:\n\n* Primary caregiver of the child with asthma seen at the community-based asthma clinic\n* Female (self-identified)\n* Black (self-identified)\n* ≥ 18 years of age\n* English-speaking\n* PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit\n\nChild:\n\n* \\\u003C18 years old for the duration of the 6-month study period\n* Publicly insured\n* Physician-diagnosed persistent asthma\n\nExclusion Criteria:\n\nMaternal:\n\n* Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)\n* Bipolar disorder or mania\n* Schizophrenia\n* Current substance abuse\u002Fdependence\n* Current serious physical intimate partner violence (IPV)\n* Lack of capacity to meaningfully participate in study procedures, as assessed by study staff during screening\n\nChild:\n\n* Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease)\n* Enrolled in another intervention with a behavioral component and\u002For novel asthma therapeutics",{"count":598,"type":24},60,[79],"The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children under the age of 18 in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are:\n\n1. Does Enhanced IPT-B decrease maternal depressive symptoms?\n2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)?\n3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?",[44,602],"Depression","2026-02-23",{"date":605,"type":57},"2026-02-24",{"date":607,"type":57},"2024-10-15",{"date":609,"type":24},"2027-03-15",{"name":611,"class":64},"Children's National Research Institute",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":19,"minAge":128,"maxAge":74,"enrollmentInfo":619,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":617,"conditions":620,"keywords":624,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":632,"locationsCount":99},"100624679","asmact-study-on-management-of-bronchial-asthma-100624679","NCT07412769","ASMact: Study on Management of Bronchial Asthma","Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.","Inclusion Criteria:\n\n* Age between 6 and 17 years\n* Presentation to the emergency department with a diagnosis of acute asthma exacerbation\n* Evaluation in the emergency department of one of the participating centers during the study periods\n\nExclusion Criteria:\n\n* Age \\\u003C 6 years or \\> 17 years\n* Diagnosis other than acute asthma exacerbation\n* Incomplete or missing clinical data\n* Patients transferred from other hospitals already treated for the same episode\n* history of allergy to any drugs used in the protocol",{"count":259,"type":24},[621,622,44,623],"Asthma Acute","Asthma Childhood","Asthma Crisis",[625],"asthma attack, exacerbation,","2026-02-13",{"date":628,"type":57},"2026-02-17",{"date":630,"type":57},"2025-11-05",{"date":284,"type":24},{"name":633,"class":64},"Meyer Children's Hospital IRCCS",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":77,"phases":645,"briefSummary":646,"conditions":647,"keywords":648,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":120},"100519477","dynamics-of-the-upper-and-lower-airway-respiratory-microbiomes-associated-with-severe-infant-asthma-100519477","NCT06044051","Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma","Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons","Microbiosthme","Inclusion Criteria:\n\n* Infants less than 24 months old\n* Follow-up by a pneumo-pediatrician for severe asthma in infants\n* Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)\n* Parent informed of the research and having signed consent\n\nExclusion Criteria:\n\n* Prematurity \\\u003C32 WA\n* Congenital heart disease with significant left to right shunt\n* Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)\n* Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)\n* Refusal of bronchial fibroscopy","24 Months",{"count":644,"type":24},100,[79],"Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.\n\nExploring and understanding these data is to improve patient care and discover new therapeutic targets.\n\nThe aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.",[44,214],[649,650],"microbiosme","Asthma in infant",{"date":628,"type":57},{"date":653,"type":57},"2023-09-26",{"date":655,"type":24},"2026-09-26",{"name":657,"class":64},"University Hospital, Rouen"]