[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638565":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Assiut University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Development Cohort",null,"Adults with non-cystic fibrosis bronchiectasis (NCFB) enrolled in the prospective observational cohort and assigned to the development subset. This cohort will be used to derive the Bronchiectasis Assessment of Severity and Exacerbations (BASE) equation, point structure, severity classification, and 12-month exacerbation-risk bands.",{"label":13,"type":10,"description":14,"interventionNames":10},"Validation Cohort","Adults with non-cystic fibrosis bronchiectasis (NCFB) enrolled in the prospective observational cohort and assigned to the validation subset. This cohort will be used to evaluate the fixed Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework without refitting, recalibration, variable substitution, or threshold modification.",[16,19,21,23],{"name":17,"affiliation":5,"role":18},"Ahmad M Shaddad, MD","PRINCIPAL_INVESTIGATOR",{"name":20,"affiliation":5,"role":18},"Aliae A. Hussien, MD",{"name":22,"affiliation":5,"role":18},"Maiada K. Hashem, MD",{"name":24,"affiliation":5,"role":18},"Alaa Sayed, MD",[26],{"name":17,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+201111171930","shaddad_ahmad@aun.edu.eg",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Assiut university-Faculty of Medicine","RECRUITING","Asyut","Asyut Egypt","71515","Egypt","EG",{"type":40,"coordinates":41},"Point",[42,43],31.18368,27.18096,{"lat":43,"lon":42},[46],{"name":17,"role":27,"phone":10,"phoneExt":10,"email":29},{"type":18,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ahmad Shaddad","Associate Professor","100638565","base-bronchiectasis-severity-and-exacerbation-risk-study-100638565",false,"NCT07599839","BASE: Bronchiectasis Severity and Exacerbation Risk Study","BASE: Bronchiectasis Assessment of Severity and Exacerbations for Baseline Severity Classification and One-Year Exacerbation Risk Prediction in Non-Cystic Fibrosis Bronchiectasis","BASE","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) based on clinical assessment and high-resolution computed tomography (HRCT).\n* Clinically stable or routinely assessed patients with non-cystic fibrosis bronchiectasis (NCFB) eligible for baseline severity and risk assessment.\n* Patients attending outpatient clinic, inpatient ward, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period.\n* Patients suitable for prospective baseline assessment using the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework.\n* Ability to undergo routine clinical, functional, radiological, oxygenation, and inflammatory assessment according to the study protocol.\n* Ability to complete planned 12-month follow-up for bronchiectasis exacerbation and outcome assessment.\n* Written informed consent obtained from the patient or legal representative.\n\nExclusion Criteria:\n\n* Cystic fibrosis-related bronchiectasis.\n* Traction bronchiectasis due to advanced fibrotic interstitial lung disease as the dominant respiratory diagnosis.\n* Active pulmonary tuberculosis at enrollment.\n* Active nontuberculous mycobacterial pulmonary disease requiring specific treatment at enrollment.\n* Active malignancy or terminal non-respiratory illness expected to prevent 12-month follow-up.\n* Acute life-threatening illness preventing safe enrollment or baseline assessment.\n* Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment.\n* Inability to complete the required baseline or Bronchiectasis Assessment of Severity and Exacerbations (BASE) assessment according to the study protocol.\n* Inability or unwillingness to complete planned 12-month follow-up.\n* Refusal to participate.","ALL","18 Years",{"count":61,"type":62},750,"ESTIMATED","OBSERVATIONAL","Non-cystic fibrosis bronchiectasis (NCFB) is a chronic airway disease characterized by permanent bronchial dilatation, impaired mucus clearance, recurrent infection, airway inflammation, and repeated exacerbations. Existing bronchiectasis severity tools are clinically useful, but many depend on prior exacerbation history, hospitalization history, subjective symptom assessment, or culture-based microbiological classification.\n\nThis prospective observational cohort study aims to develop and validate the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework. BASE is designed to classify current bronchiectasis severity and predict 12-month exacerbation risk using objective baseline functional, radiological, oxygenation, and inflammatory variables. Detailed methodological specifications, including variable definitions, scoring architecture, endpoint hierarchy, development-validation governance, and analytical integrity rules, are archived in a restricted-access Zenodo record: https:\u002F\u002Fdoi.org\u002F10.5281\u002Fzenodo.20143505\n\n.\n\nParticipants will receive routine clinical care, and no treatment or intervention will be assigned by the study protocol. Patients will be followed for 12 months to record bronchiectasis exacerbations, hospitalization, lung-function change, inflammatory marker change, and clinical outcomes. The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework includes two linked baseline models: the BASE Severity model (BASE-S) for current bronchiectasis severity classification and the BASE Prognostic model (BASE-P) for prediction of 12-month exacerbation risk. Both models will be derived in the development cohort and applied unchanged to the validation cohort.",[66,67,68],"Bronchiectasis","Non-cystic Fibrosis Bronchiectasis","Bronchiectasis With Acute Exacerbation",[70,66,71,72,73,74,75,76,77],"Non-cystic fibrosis bronchiectasis (NCFB)","Bronchiectasis severity","Bronchiectasis exacerbation","Exacerbation risk","One-year exacerbation risk","Baseline risk prediction","Disease-signature model","Prospective observational cohort","2026-05-15",{"date":80,"type":81},"2026-05-20","ACTUAL",{"date":83,"type":81},"2025-09-11",{"date":85,"type":62},"2027-02-01",{"name":5,"class":6},1]