[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454016":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":59,"collaborators":18,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":18,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypertonic Saline inhalation","EXPERIMENTAL","Participants randomized to the Hypertonic Saline inhalation arm will be prescribed a nebulizer for Hypertonic Saline Inhalation (5ml, 5.8%) two times a day for 12 weeks. Participants will also receive best supportive care for 12 weeks (see below).",[13],"Device: Hypertonic Saline inhalation",{"label":15,"type":16,"description":17,"interventionNames":18},"Best supportive care","NO_INTERVENTION","Participants randomized to the best supportive care arm will receive standard of care including management of predisposing (lung) disease, guidance in smoking cessation, respiratory physiotherapy (e.g. airway clearance), nutritional guidance, but no antimycobacterial treatment.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Hypertonic Saline inhalation is thought to increase mucociliary clearance of the airways",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Arthur Lemson, MSc","CONTACT","+31634265743","arthur.lemson@radboudumc.nl",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Wouter Hoefsloot, MSc, PhD","+31612569107","wouter.hoefsloot@radboudumc.nl",[35],{"facility":5,"status":36,"city":37,"state":18,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Nijmegen","6225GA","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],5.85278,51.8425,{"lat":45,"lon":44},[48,50,53,55,57],{"name":49,"role":27,"phone":28,"phoneExt":18,"email":29},"Arthur Lemson, MD",{"name":51,"role":27,"phone":52,"phoneExt":18,"email":33},"Wouter Hoefsloot, MD, PhD","+31611072569",{"name":49,"role":54,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":51,"role":56,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":56,"phone":18,"phoneExt":18,"email":18},"Martin Boeree, MD, PhD",{"type":60,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100454016","phase-4-hypertonic-saline-inhalation-for-mycobacterium-avium-complex-pulmonary-disease-100454016",false,"NCT05192057","Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease","A Randomized Controlled Trial on Hypertonic Saline Inhalation in Patients With Nodular-bronchiectatic Mycobacterium Avium Complex Pulmonary Disease","SALINE","Inclusion Criteria:\n\n* International guideline criteria for nodular-bronchiectatic MAC lung disease, i.e. symptomatic, nodular bronchiectatic lesions seen on thorax radiography and ≥2 positive cultures of the same MAC species or one positive culture from a bronchoalveolar lavage;\n* ≥1 positive MAC sputum cultures must be collected in the previous 4 months;\n* Signed and dated patient informed consent.\n\nExclusion Criteria:\n\n* Fibrocavitary MAC lung disease;\n* Antimycobacterial treatment in the last 6 months;\n* Previous MAC lung disease treatment failure, defined as persistent culture positivity despite \\>6 months of guideline-recommended treatment;\n* Current clinical relevant asthma or otherwise bronchial hyperresponsiveness that is judged to be a contra-indication for HSi.\n* Current HSi use\n* Former adverse reaction to HSi (note: former HSi use that was stopped due to a lack of clinical improvement is not an exclusion criterium);\n* Hypertonic saline intolerability during the screening test inhalation\n* Diagnosis of HIV;\n* Diagnosis of Cystic fibrosis (CF);\n* Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;\n* Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment\n* Current use of chronic systemic corticosteroids at doses of 15 mg\u002Fday for more than 3 months\n* Prior lung or other solid organ transplant\n* Known or suspected current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient.","ALL","18 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with Mycobacterium avium complex lung disease and compare the effect to treatment with best supportive care alone.",[79,80],"Nontuberculous Mycobacterial Lung Disease","Mycobacterium Avium Complex","2025-06-25",{"date":83,"type":84},"2025-06-26","ACTUAL",{"date":86,"type":84},"2022-05-20",{"date":88,"type":73},"2026-10-01",{"name":5,"class":6},1]