[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596653":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":144,"collaborators":31,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":31,"eligibilityCriteria":152,"healthyVolunteers":148,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":31,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CSL787 High Dose","EXPERIMENTAL","Participants in this arm will receive a high dose of CSL787.",[13,14],"Biological: CSL787","Device: Nebulizer",{"label":16,"type":10,"description":17,"interventionNames":18},"CSL787 Low Dose","Participants in this arm will receive a low dose of CSL787.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Participants in this arm will receive placebo.",[24,14],"Drug: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","CSL787","CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.",[9,16],null,{"type":33,"name":20,"description":34,"armGroupLabels":35,"otherNames":31},"DRUG","Participants will receive a matching volume of placebo QD over a period of 6 to 12 months.",[20],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"DEVICE","Nebulizer","The nebulizer is a CE-marked device.",[9,16,20],[42],{"name":43,"affiliation":5,"role":44},"Study Director","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Trial Registration Coordinator","CONTACT","+1 610-878-4697","clinicaltrials@cslbehring.com",[52,58,67,77,85,93,96,104,112,120,123,131,136],{"facility":53,"status":54,"city":55,"state":31,"zip":31,"country":56,"countryCode":57,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"The Prince Charles Hospital","RECRUITING","Queensland","Australia","AU",{"facility":59,"status":54,"city":60,"state":31,"zip":31,"country":56,"countryCode":57,"cosmosGeoPoint":61,"geoPoint":66,"contacts":31},"Westmead Hospital","Westmead",{"type":62,"coordinates":63},"Point",[64,65],150.98768,-33.80383,{"lat":65,"lon":64},{"facility":68,"status":54,"city":69,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":31},"Fukuoka University Chikushi Hopsital","Chikushino-shi","Japan","JP",{"type":62,"coordinates":73},[74,75],130.5156,33.49631,{"lat":75,"lon":74},{"facility":78,"status":54,"city":79,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":80,"geoPoint":84,"contacts":31},"Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers","Fukuoka",{"type":62,"coordinates":81},[82,83],130.41667,33.6,{"lat":83,"lon":82},{"facility":86,"status":54,"city":87,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":88,"geoPoint":92,"contacts":31},"Ibaraki Prefectural Central Hospital","Ibaraki",{"type":62,"coordinates":89},[90,91],135.56828,34.81641,{"lat":91,"lon":90},{"facility":94,"status":54,"city":95,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"Kazunori Tobino Iizuka Hospital","Iizuka-shi",{"facility":97,"status":54,"city":98,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":99,"geoPoint":103,"contacts":31},"National Hospital Organization Minami Kyoto Hospital","Kyoto",{"type":62,"coordinates":100},[101,102],135.75385,35.02107,{"lat":102,"lon":101},{"facility":105,"status":54,"city":106,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":107,"geoPoint":111,"contacts":31},"Matsusaka Municipal Hospital","Mie",{"type":62,"coordinates":108},[109,110],131.58333,32.96667,{"lat":110,"lon":109},{"facility":113,"status":54,"city":114,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":115,"geoPoint":119,"contacts":31},"National Hospital Organization Kinki Chuo Chest Medical Center","Osaka",{"type":62,"coordinates":116},[117,118],135.50107,34.69379,{"lat":118,"lon":117},{"facility":121,"status":54,"city":122,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"Shimonoseki City Hospital","Shimonoseki-shi",{"facility":124,"status":54,"city":125,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":126,"geoPoint":130,"contacts":31},"Japan Anti-Tuberculosis Association, Fukujuji Hospital","Tokyo",{"type":62,"coordinates":127},[128,129],139.69171,35.6895,{"lat":129,"lon":128},{"facility":132,"status":54,"city":125,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":133,"geoPoint":135,"contacts":31},"Keio University Hospital",{"type":62,"coordinates":134},[128,129],{"lat":129,"lon":128},{"facility":137,"status":54,"city":138,"state":31,"zip":31,"country":70,"countryCode":71,"cosmosGeoPoint":139,"geoPoint":143,"contacts":31},"National Hospital Organization Mie Chuo Medical Center","Tsu",{"type":62,"coordinates":140},[141,142],136.51667,34.73333,{"lat":142,"lon":141},{"type":145,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100596653","phase-2-dose-range-finding-efficacy-and-safety-study-of-nebulized-csl787-in-adults-with-non-cystic-fibrosis-bronchiectasis-ncfb-100596653",false,"NCT07048262","Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)","A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 Years) With Non-cystic Fibrosis Bronchiectasis","Inclusion Criteria:\n\n* Adult between the ages of 18 to 85 years\n* Primary diagnosis of NCFB confirmed by chest computed tomography (CT) scan, where bronchiectasis has been documented by a radiologist. Diagnosis in the medical records based on historical scans is acceptable if the chest CT scan confirming the participant's NCFB diagnosis was performed within 12 months before enrollment. Participants for whom no chest CT scan results are available within the previous 12 months will undergo a chest CT scan during the Screening Period\n* Exacerbation history within the previous 1 year defined as either 1 of the following:\n* \\>= 2 documented exacerbations requiring oral and\u002For intravenous (IV) antibiotic therapy to treat a pulmonary infection.\n\nOR\n\n* 1 documented exacerbation requiring oral and\u002For IV antibiotic therapy to treat a pulmonary infection and a St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \\> 40 at Screening.\n* Note: Other medications to treat NCFB such as: oral macrolides, or dipeptidyl peptidase-1 (DPP-1) inhibitors are allowed, provided \\>= 1 historical exacerbation occurred while on the medication for \\>= 3 months at a stable dose.\n* Postbronchodilator percentage of the predicted normal forced expiratory volume in 1 second of expiration \\[FEV1% predicted\\] \\> 35% and forced expiratory volume in 1 second (FEV1) \\>= 1 liter (L) obtained in accordance with American Thoracic Society (ATS) \u002F European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline.\n\nExclusion Criteria:\n\n* History of bronchospasm in response to inhaled therapies including inhaled antibiotics\n* Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other immunoglobulin.\n* Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma or, diffuse panbronchiolitis (DPB), as determined by the investigator.\n* Pulmonary exacerbation requiring antibiotic therapy within the 4 weeks before Baseline.","ALL","18 Years","85 Years",{"count":157,"type":158},450,"ESTIMATED","INTERVENTIONAL",[161],"PHASE2","This study is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose range finding study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (immunoglobulin G \\[IgG\\] inhalation solution) compared with placebo over a period of 6 to 12 months independent of the occurrence of pulmonary exacerbations.\n\nThe primary aim of the study is to characterize the overall effect of CSL787 as well as the dose response of 2 active treatment regimens of inhaled CSL787 administered to participants with NCFB toward prolonging the TTF exacerbation.",[164],"Non-cystic Fibrosis Bronchiectasis",[166,167,168],"Chronic respiratory disease","Inflammation","Chronic bacterial infection","2025-11-06",{"date":171,"type":172},"2025-11-10","ACTUAL",{"date":174,"type":172},"2025-09-03",{"date":176,"type":158},"2028-03-28",{"name":5,"class":6},13]