NCT07599839 BASE: Bronchiectasis Severity and Exacerbation Risk Study
| NCT ID | NCT07599839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assiut University |
| Condition | Bronchiectasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2025-09-11 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ahmad M Shaddad, MD
PRINCIPAL INVESTIGATOR
Assiut University
Frequently Asked Questions
Who can join the NCT07599839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07599839 currently recruiting?
Yes, NCT07599839 is actively recruiting participants. Contact the research team at shaddad_ahmad@aun.edu.eg for enrollment information.
Where is the NCT07599839 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT07599839 clinical trial?
NCT07599839 is sponsored by Assiut University. The principal investigator is Ahmad M Shaddad, MD at Assiut University. The trial plans to enroll 750 participants.