NCT07599839Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 15 May 2026
- Start date
- 11 Sept 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Assiut University
- Diseases
- Cystic fibrosis
- NCT number
- NCT07599839
What you commit to
- Study type: Observational
- Planned participants: 750
- From 11 Sept 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment.
Other illness
- 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.
Other
- Cystic fibrosis-related bronchiectasis.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut University- Faculty of Medicine Coordinator of this site? Confirm its status | Asyut | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.