BASE: Bronchiectasis Severity and Exacerbation Risk Study

NCT07599839 · tracked via the Priya Life Science Egypt tracker

Sponsor

Assiut University

Phase

Observational

Started

2025-09-11

Last updated

2026-05-20

Condition(s) studied

BronchiectasisNon-cystic Fibrosis BronchiectasisBronchiectasis With Acute Exacerbation

Study 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

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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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Cystic fibrosis-related bronchiectasis. * Traction bronchiectasis due to advanced fibrotic interstitial lung disease as the dominant respiratory diagnosis. * Active pulmonary tuberculosis at enrollment. * Active nontuberculous mycobacterial pulmonary disease requiring specific treatment at enrollment. * Active malignancy or terminal non-respiratory illness expected to prevent 12-month follow-up. * Acute life-threatening illness preventing safe enrollment or baseline assessment. * Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment. * Inability to complete the required baseline or Bronchiectasis Assessment of Severity and Exacerbations (BASE) assessment according to the study protocol. * Inability or unwillingness to complete planned 12-month follow-up. * Refusal to participate.

Primary outcome measure(s)

Twelve-Month Bronchiectasis Exacerbation Risk Predicted by the BASE Prognostic Model (BASE-P) — Baseline to 12 months follow-up.
Occurrence of at least one bronchiectasis exacerbation during 12-month follow-up, used as the primary clinical endpoint for development and validation of the BASE Prognostic model (BASE-P). BASE-P is the 12-month risk-prediction component of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework for adults with non-cystic fibrosis bronchiectasis (NCFB). Specific point ranges and risk categories have not yet been established and will be derived in the development cohort before locked validation. Higher BASE-P predicted risk values indicate higher expected exacerbation risk. Unit of Measure: Percentage of participants.

Trial sites (1)

Facility	City	Region	Status
Assiut university-Faculty of Medicine	Asyut	Asyut Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07599839 on ClinicalTrials.gov ↗ ← All trials in Egypt