Actively Recruiting
BASE: Bronchiectasis Assessment of Severity and Exacerbations for Baseline Severity Classification and One-Year Exacerbation Risk Prediction in Non-Cystic Fibrosis Bronchiectasis
Led by Assiut University · Updated on 2026-05-20
750
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic lung condition marked by permanent airway widening, poor mucus clearance, frequent infections, ongoing inflammation, and repeated flare-ups. Researchers are evaluating the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework to classify disease severity and predict the risk of flare-ups within 12 months using objective clinical and laboratory measures. The study is a prospective observational cohort aimed at developing and validating this new assessment tool for adults with NCFB. Participants will continue their usual medical care without any treatments assigned by the study. They will be divided into two groups: a development cohort to create the BASE model, and a validation cohort to test the model without changes. Assessments include baseline clinical exams, lung function tests, chest imaging reviews, oxygen level measurements, and blood markers of inflammation. Follow-up will last for 12 months to track flare-ups, hospitalizations, lung function changes, inflammation levels, treatment changes, and clinical outcomes. During the study, participants will undergo regular evaluations and data collection to support the development and validation of the BASE framework. Researchers will measure the accuracy of the BASE model in classifying current disease severity and predicting future flare-up risk. Safety and health outcomes will be monitored throughout the year, with detailed data recorded at scheduled intervals. The study's goal is to provide a practical tool for managing NCFB severity and risk while patients receive their standard care.
CONDITIONS
Brief Title
BASE: Bronchiectasis Severity and Exacerbation Risk Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 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 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 will not qualify if you...
- 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 BASE assessment according to the study protocol
- Inability or unwillingness to complete planned 12-month follow-up
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline Day 1
Participants undergo baseline clinical assessment, pulmonary function tests, chest imaging review, oxygenation assessment, and inflammatory marker assessment to establish current disease severity and risk profile.
1 baseline visit (in-person)
Duration - 12 months
Participants are followed for 12 months to monitor bronchiectasis exacerbations, lung function changes, inflammatory markers, treatment escalation, and clinical outcomes without any study-assigned intervention.
Follow-up visits as per routine clinical care over 12 months
Trial Site Locations
Total: 1 location
1
Assiut university-Faculty of Medicine
Asyut, Asyut Egypt, Egypt, 71515
Actively Recruiting
Research Team
A
Ahmad M Shaddad, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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