[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633713":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome",[13,14,15],"Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B","Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B","Radiation: SPECT\u002FCT scan",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm B","First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","12 mg of nebulised 99mTc-liposomal amphotericin B","All enrolled subjects will receive nebulised liposomal amphotericin B in addition to standard care. Subjects will be randomly assigned to one of two dosage levels: 12 mg or 24 mg. As this study follows a crossover design, each participant will eventually receive both dosages. Each nebulisation session will have a duration of 10 to 20 minutes, separated by a 14-day washout period between the two sessions",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"24 mg of nebulised 99mTc-liposomal amphotericin B","All enrolled subjects will receive nebulised AmBisome in addition to standard care. Subjects will be randomly assigned to one of two dosage levels: 12 mg or 24 mg. As this study follows a crossover design, each participant will eventually receive both dosages. Each nebulisation session will have a duration of 10 to 20 minutes, separated by a 14-day washout period between the two sessions.",[9,17],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"RADIATION","SPECT\u002FCT scan","After both nebulisation sessions, a SPECT\u002FCT scan will determine 99mTc-liposomal amphotericin B localization",[9,17],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Laura A Michon, MSc","CONTACT","+3124 361 1111","laura.michon@radboudumc.nl",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Radboudumc","Nijmegen","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],5.85278,51.8425,{"lat":52,"lon":51},[55],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[59],{"name":60,"class":61},"Gilead Sciences","INDUSTRY","100633713","phase-1-deposition-of-inhaled-liposomal-amphotericin-b-in-chronic-pulmonary-aspergillosis-cpa-100633713",false,"NCT07530263","Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)","Nebulised lIposomal aMphotericin B in Chronic pUlmonary aSpergillosis: a Deposition Study","NIMBUS","Inclusion Criteria:\n\n* The patient is at least 18 years old on the day of inclusion.\n* The patients has been diagnosed with chronic pulmonary aspergillosis.\n* There is no significant interference with standard care and follow-up.\n\nExclusion Criteria:\n\n* The patient is breastfeeding, or of childbearing potential and is pregnant, planning to become pregnant within 3 months of the SPECT imaging, unable to provide a negative pregnancy test at screening, or unwilling to use effective contraception during the study and for at least 3 months after the last SPECT scan.\n* The patient is not able to lie supine in the scanner.\n* The patient has previously reported intolerance to inhalation medication.\n* The patient is unable to provide informed consent due to lack of decision-making capacity.","ALL","18 Years",{"count":73,"type":74},18,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","This study evaluates and aims to optimize inhalation treatment with nebulized liposomal amphotericin B in patients with chronic pulmonary aspergillosis. The primary objective is to assess the pulmonary deposition and intrapulmonary distribution of liposomal amphotericin B after nebulization, using technetium-99m-labeled liposomal amphotericin B and SPECT\u002FCT imaging. The study also aims to generate data to inform optimization of inhalation treatment design.\n\nParticipants will receive two different doses of nebulized liposomal amphotericin B (12 mg and 24 mg) on separate study days. After each administration, participants will undergo SPECT\u002FCT imaging to assess pulmonary deposition. Blood samples will be collected on both study days and after study treatment to evaluate safety and measure systemic amphotericin B concentrations. Participants will also perform spirometry using a handheld device and complete a treatment satisfaction questionnaire on both study days.",[80],"Chronic Pulmonary Aspergillosis",[82,83,84,85,86],"ambisome","liposomal amphotericin B","nebulization","chronic pulmonary aspergillosis","deposition","NOT_YET_RECRUITING","2026-04-09",{"date":90,"type":91},"2026-04-15","ACTUAL",{"date":93,"type":74},"2026-05-01",{"date":95,"type":74},"2027-06-01",{"name":5,"class":6},1]