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BASE: Bronchiectasis Assessment of Severity and Exacerbations for Baseline Severity Classification and One-Year Exacerbation Risk Prediction in Non-Cystic Fibrosis Bronchiectasis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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. This 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://doi.org/10.5281/zenodo.20143505 . Participants 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Adult patients aged 18 years or older.

• Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) based on clinical assessment and high-resolution computed tomography (HRCT).

• Clinically stable or routinely assessed patients with non-cystic fibrosis bronchiectasis (NCFB) eligible for baseline severity and risk assessment.

• Patients attending outpatient clinic, inpatient ward, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period.

• Patients suitable for prospective baseline assessment using the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework.

• Ability to undergo routine clinical, functional, radiological, oxygenation, and inflammatory assessment according to the study protocol.

• Ability to complete planned 12-month follow-up for bronchiectasis exacerbation and outcome assessment.

• Written informed consent obtained from the patient or legal representative.

Locations
Other Locations
Egypt
Assiut university-Faculty of Medicine
RECRUITING
Asyut
Contact Information
Primary
Ahmad M Shaddad, MD
shaddad_ahmad@aun.edu.eg
+201111171930
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 750
Treatments
Development Cohort
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov