[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511892":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":78,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":31,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":31,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Low Dose inspiratory muscle rehabilitation (IMR) group","EXPERIMENTAL","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).",[13],"Device: Pro2 - Low Dose - 40% of participant's MIP",{"label":15,"type":10,"description":16,"interventionNames":17},"Active High Dose inspiratory muscle rehabilitation (IMR) group","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP (maximum inspiratory pressure).",[18],"Device: Pro2 - High Dose - 75% of participant's MIP",{"label":20,"type":21,"description":22,"interventionNames":23},"SHAM","ACTIVE_COMPARATOR","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).",[24],"Device: Pro2 - SHAM - 15% of participant's MIP",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Pro2 - Low Dose - 40% of participant's MIP","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS\u002FAndroid devices or Mac\u002FWindows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Pro2 - High Dose - 75% of participant's MIP","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS\u002FAndroid devices or Mac\u002FWindows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP (maximum inspiratory pressure).",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Pro2 - SHAM - 15% of participant's MIP","Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS\u002FAndroid devices or Mac\u002FWindows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that participants achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).",[20],[41],{"name":42,"affiliation":5,"role":43},"Jason Lang, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":31,"email":48},"CONTACT","9196843364","jason.lang@duke.edu",[50,67],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Duke Health Center Creekstone","RECRUITING","Durham","North Carolina","27703","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-78.89862,35.99403,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":47,"phoneExt":31,"email":48},"Jason Lang",{"facility":68,"status":52,"city":53,"state":54,"zip":69,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Duke Healthy Lifestyles Clinic","27704",{"type":59,"coordinates":71},[61,62],{"lat":62,"lon":61},[74],{"name":75,"role":46,"phone":76,"phoneExt":31,"email":77},"Veronica Carrion, BS","9197041523","vmp19@duke.edu",{"type":79,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[81],{"name":82,"class":83},"National Institutes of Health (NIH)","NIH","100511892","mechanistic-study-of-inspiratory-training-in-childhood-asthma-mica-100511892",false,"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","ALL","6 Years","17 Years",{"count":95,"type":96},76,"ESTIMATED","INTERVENTIONAL",[99],"NA","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",[102,103,104,105],"Asthma in Children","Obesity","Pediatric Obesity","Pediatric Asthma","2025-08-18",{"date":108,"type":109},"2025-08-19","ACTUAL",{"date":111,"type":109},"2024-08-01",{"date":113,"type":96},"2027-10-30",{"name":5,"class":6},2]