BASE: Bronchiectasis Severity and Exacerbation Risk Study

NCT07599839 | Recruiting

• 2 other identifiers: 2026-37-510.5281/zenodo.20143505
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiectasis; Non-cystic Fibrosis Bronchiectasis; Bronchiectasis With Acute Exacerbation

Keywords

Non-cystic fibrosis bronchiectasis (NCFB); Bronchiectasis; Bronchiectasis severity; Bronchiectasis exacerbation; Exacerbation risk; One-year exacerbation risk; Baseline risk prediction; Disease-signature model; Prospective observational cohort

Outcome Measures

Primary Outcomes (1)

• Twelve-Month Bronchiectasis Exacerbation Risk Predicted by the BASE Prognostic Model (BASE-P)

  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.

  Baseline to 12 months follow-up.

Secondary Outcomes (13)

• Current Bronchiectasis Severity Classification by the BASE Severity Model (BASE-S)

  Baseline Day 1

• Time to First Bronchiectasis Exacerbation

  Baseline to 12 months follow-up.

• Number of Bronchiectasis Exacerbations During Follow-Up

  Baseline to 12 months follow-up.

• Severe Bronchiectasis Exacerbation Requiring Hospitalization

  Baseline to 12 months follow-up.

• Change in Forced Expiratory Volume in One Second Percent Predicted (FEV1% Predicted)

  Baseline to 12 months follow-up.

Other Outcomes (10)

• Discrimination Performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework for Twelve-Month Bronchiectasis Exacerbation Risk

  Baseline to 12 months follow-up.

• Calibration Performance of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework for Twelve-Month Bronchiectasis Exacerbation Risk

  Baseline to 12 months follow-up.

• Clinical Utility of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework

  Baseline to 12 months follow-up.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with non-cystic fibrosis bronchiectasis (NCFB) attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period will be prospectively screened for eligibility. Eligible participants will have clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) and will undergo baseline assessment using the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework, followed by 12-month follow-up for bronchiectasis exacerbations, hospitalization, functional change, inflammatory marker change, and clinical outcomes. Participants will receive routine clinical care, and no treatment or intervention will be assigned by the study protocol.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university-Faculty of Medicine

Asyut, Asyut Egypt, 71515, Egypt

RECRUITING

Related Links

• Locked BASE Version 1.0 methodological archive including protocol, statistical analysis plan, disclosure materials, baseline severity-classification framework, 12-month exacerbation-risk prediction framework, and development-validation governance.

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Ahmad M Shaddad, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Maiada K. Hashem, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Alaa Sayed, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M Shaddad, MD

CONTACT

+201111171930; shaddad_ahmad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 20, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the primary study results and for 3 years thereafter.
• Access Criteria: Access may be granted to qualified researchers submitting a methodologically sound proposal for scientific purposes related to non-cystic fibrosis bronchiectasis (NCFB). Requests must be reviewed and approved by the principal investigator and institutional authority. Approved requesters must sign a data use agreement covering confidentiality, restricted use, data security, no re-identification attempts, no unauthorized redistribution, and acknowledgement of the investigators and Assiut University.

Locations

EG (1)