[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578826":3},{"organization":4,"armGroups":7,"interventions":59,"overallOfficials":102,"centralContacts":112,"locations":121,"responsibleParty":139,"collaborators":65,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":65,"eligibilityCriteria":148,"healthyVolunteers":145,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":65,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":124,"whyStopped":65,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,14,19,24,29,34,39,44,49,54],{"label":9,"type":10,"description":11,"interventionNames":12},"pMDI alone","ACTIVE_COMPARATOR","patients use pMDI directly without spacer",[13],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI alone",{"label":15,"type":10,"description":16,"interventionNames":17},"Able spacer","patients use pMDI connected to the Able spacer",[18],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Able spacer",{"label":20,"type":10,"description":21,"interventionNames":22},"Tips-Haler spacer","patients use pMDI connected to the Tips-Haler spacer",[23],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connectec to Tips-Haler spacer",{"label":25,"type":10,"description":26,"interventionNames":27},"Aerochaber plus flow vu valved holding chamber","patients use pMDI connected to the Aerochaber plus flow vu valved holding chamber",[28],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Aerochamber plus flow vu valved holding chamber",{"label":30,"type":10,"description":31,"interventionNames":32},"Atomizer chamber","patients use pMDI connected to the Atomizer chamber",[33],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Atomizer chamber spacer",{"label":35,"type":10,"description":36,"interventionNames":37},"plastic juice cup","patients use pMDI connected to a plastic juice cup",[38],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to plastic juice cup spacer",{"label":40,"type":10,"description":41,"interventionNames":42},"DispozABLE Spacer","patients use pMDI connected to the DispozABLE Spacer",[43],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the DispozABLE spacer",{"label":45,"type":10,"description":46,"interventionNames":47},"Lite-Aire Valved holding chamber","patients use pMDI connected to the Lite-Aire Valved holding chamber",[48],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer",{"label":50,"type":10,"description":51,"interventionNames":52},"ventoline package","patients use pMDI connected to the ventoline package spacer",[53],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the MDI package",{"label":55,"type":10,"description":56,"interventionNames":57},"paper sheet spacer","patients use pMDI connected to the paper sheet spacer",[58],"Drug: Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the hand-made paper sheet spacer",[60,66,70,74,78,82,86,90,94,98],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Ventoline® Evohaler® 100 µg\u002Finhalation pMDI alone","patients use ventoline pMDI alone",[9],null,{"type":61,"name":67,"description":68,"armGroupLabels":69,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Able spacer","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Able spacer",[15],{"type":61,"name":71,"description":72,"armGroupLabels":73,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connectec to Tips-Haler spacer","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connectec to Tips-Haler spacer",[20],{"type":61,"name":75,"description":76,"armGroupLabels":77,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Aerochamber plus flow vu valved holding chamber","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Aerochamber plus flow vu valved holding chamber",[25],{"type":61,"name":79,"description":80,"armGroupLabels":81,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Atomizer chamber spacer","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to Atomizer chamber spacer",[30],{"type":61,"name":83,"description":84,"armGroupLabels":85,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to plastic juice cup spacer","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to plastic juice cup spacer",[35],{"type":61,"name":87,"description":88,"armGroupLabels":89,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the DispozABLE spacer","patient use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the DispozABLE spacer",[40],{"type":61,"name":91,"description":92,"armGroupLabels":93,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the Lite-Aire collapsible valved holding chamber spacer",[45],{"type":61,"name":95,"description":96,"armGroupLabels":97,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the MDI package","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the MDI package",[50],{"type":61,"name":99,"description":100,"armGroupLabels":101,"otherNames":65},"Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the hand-made paper sheet spacer","patients use Ventoline® Evohaler® 100 µg\u002Finhalation pMDI connected to the hand-made paper sheet spacer",[55],[103,107,110],{"name":104,"affiliation":105,"role":106},"Mohamed Emam Abdelrahim, professor","Beni-Suef","STUDY_CHAIR",{"name":108,"affiliation":105,"role":109},"Haitham Saeed Abdel-Azeez, Associate professor","STUDY_DIRECTOR",{"name":111,"affiliation":105,"role":109},"Nabila Ibrahim Abdel Mageed Laz, professor",[113,118],{"name":114,"role":115,"phone":116,"phoneExt":65,"email":117},"Omar Ahmed Sayed, Demonstrator","CONTACT","+201152677683","OmarAhmed@pharm.bsu.edu.eg",{"name":114,"role":115,"phone":119,"phoneExt":65,"email":120},"+201090313474","omarahmedsayed1111@gmail.com",[122],{"facility":123,"status":124,"city":125,"state":126,"zip":65,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"Beni-Suef university hospital","RECRUITING","Banī Suwayf","Egypt","EG",{"type":129,"coordinates":130},"Point",[131,132],31.09785,29.07441,{"lat":132,"lon":131},[135],{"name":136,"role":115,"phone":137,"phoneExt":65,"email":138},"university hospital, manager","022319397 - 02317953","doaamahmoud@med.bsu.edu.eg",{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"PRINCIPAL_INVESTIGATOR","Omar Ahmed Sayed","Demonstrator","100578826","phase-4-assessment-of-emergency-spacers-versus-traditional-spacers-for-delivery-of-aerosolized-drugs-100578826",false,"NCT06816342","Assessment of Emergency Spacers Versus Traditional Spacers for Delivery of Aerosolized Drugs","Inclusion Criteria:\n\n• Mild and moderate asthmatic patients aged from 6 - 80 year old.\n\nExclusion Criteria:\n\n* Severe asthmatics or patients admitted to an intensive care unit\n* ischemic heart disease\n* recent abdominal surgery\n* inability to perform properly the pulmonary function tests\n* hepatic or renal impairment\n* hypersensitivity to salbutamol.","ALL","6 Years","80 Years",{"count":153,"type":154},120,"ESTIMATED","INTERVENTIONAL",[157],"PHASE4","* The goal of this clinical trial is to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs using pMDI. in young children and adult asthmatic patients The main questions it aims to answer are:\n\n  1. Measuring total emitted dose emitted from pMDI alone and attached to spacers.\n  2. Determining the pharmacokinetic parameter of aerosol delivered by different spacers.\n  3. Determining the lung bioavailability of aerosol delivered by different spacers.\n  4. Determining the systemic bioavailability of aerosol delivered by different spacers.\n  5. Determining the lung function after aerosol delivered by different spacers.\n  6. Determining the safety Researchers will compare salbutamol amount delivered using pMDI alone and pMDI connected to differents spacers to evaluate the performance, feasibility, and safety of emergency spacers compared to traditional spacers for the delivery of aerosolized drugs.\n\n     Participants will asked to\n* inhale salbutamol through pMDI alone and pMDI connected to different spacers\n* perform lung function test using spirometer\n* urine samples will be taken from patients 30 minutes and 24 hours after dose inhalation.\n* use pulse oximeter to measure heart rate",[160,161,162],"Asthmatic Patients","MDI","Aerosol Generating Procedure",[164,165,166,167,168],"pMDI","valved holding chamber","salbutamol","Aerosol delivery","emergency spacers","2025-02-06",{"date":171,"type":172},"2025-02-10","ACTUAL",{"date":174,"type":172},"2024-11-01",{"date":171,"type":154},{"name":5,"class":6},1]