BronchiectasisBASENCT07599839
BASE: Bronchiectasis Severity and Exacerbation Risk Study
An observational study of Bronchiectasis and Non-cystic Fibrosis Bronchiectasis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Non-cystic Fibrosis Bronchiectasis, Bronchiectasis With Acute Exacerbation
- How many people
- 750 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university-Faculty of Medicine
Asyut, Asyut Egypt, 71515
Ahmad M Shaddad, MD, shaddad_ahmad@aun.edu.eg
About this study
Official title: BASE: Bronchiectasis Assessment of Severity and Exacerbations for Baseline Severity Classification and One-Year Exacerbation Risk Prediction in Non-Cystic Fibrosis Bronchiectasis
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
Read more
.
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.
Read the detailed description
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic airway disease characterized by permanent bronchial dilatation, impaired mucociliary clearance, recurrent infection, persistent airway inflammation, and repeated exacerbations. Disease severity and future exacerbation risk are heterogeneous among patients, and accurate baseline risk stratification remains clinically important for follow-up planning, preventive strategies, and early identification of patients at higher risk of clinical deterioration.
Existing bronchiectasis severity tools provide useful clinical stratification, but several established approaches include variables such as previous exacerbation history, previous hospitalization, subjective dyspnea assessment, or culture-based microbiological classification. These variables may be influenced by health-care access, documentation quality, patient perception, physician decision thresholds, sputum sampling quality, timing of culture, and prior antibiotic exposure. Therefore, there is a need to evaluate whether a focused objective disease-signature framework can classify current disease severity and predict future exacerbation risk using baseline functional, radiological, oxygenation, and inflammatory variables.
The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework is designed as a baseline clinical assessment model for adults with non-cystic fibrosis bronchiectasis (NCFB). The 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 bronchiectasis exacerbation risk. Detailed variable definitions, scoring rules, point-conversion methods, endpoint hierarchy, development-validation governance, and analytic specifications are archived in a restricted-access Zenodo record before final model derivation and validation: https://doi.org/10.5281/zenodo.20143505
.
This is a prospective observational cohort study. Participants will not be assigned to any treatment or intervention by the study protocol. All clinical management decisions, including airway clearance, antibiotic treatment, inhaled therapy, microbiological testing, follow-up frequency, and hospitalization decisions, will follow routine clinical care and institutional practice.
Eligible participants will undergo baseline clinical assessment, pulmonary function assessment, chest imaging review, resting room-air oxygenation assessment, and inflammatory marker assessment. Follow-up will continue for 12 months. During follow-up, bronchiectasis exacerbations, severe exacerbations requiring hospitalization, lung-function change, inflammatory marker change, treatment escalation, and clinical outcomes will be recorded using structured data collection forms.
The study will use a development-validation design. The BASE-S and BASE-P equations, point structures, severity categories, and risk bands will be derived in the development cohort. The final locked models will then be applied unchanged to the validation cohort. No refitting, recalibration, variable substitution, point-score modification, or threshold retuning will be performed in the validation cohort. Model performance will be assessed using discrimination, calibration, risk-band separation, clinical utility where applicable, and comparison with established bronchiectasis severity tools where complete data are available.
The intended output is a practical baseline disease-signature framework that can support severity classification and one-year exacerbation-risk prediction in adults with non-cystic fibrosis bronchiectasis (NCFB), while preserving separation from any future interventional treatment studies.
- 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
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months follow-up.
Secondary outcomes (13)
Current Bronchiectasis Severity Classification by the BASE Severity Model (BASE-S)
Baseline bronchiectasis severity classification using the BASE Severity model (BASE-S). BASE-S is the current severity-classification component of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework for adults with non-cystic fibrosis bronchiectasis (NCFB). Specific severity point ranges and categories have not yet been established and will be derived in the development cohort before locked validation. Higher BASE-S severity categories indicate greater baseline bronchiectasis disease burden. Unit of Measure: Percentage of participants.
Measured: Baseline Day 1
Time to First Bronchiectasis Exacerbation
Time from baseline assessment to the first recorded bronchiectasis exacerbation during follow-up. Participants without exacerbation will be censored at the last available follow-up date or at 12 months. Shorter time to first bronchiectasis exacerbation indicates earlier clinical deterioration and worse outcome. Unit of Measure: Days.
Measured: Baseline to 12 months follow-up.
Number of Bronchiectasis Exacerbations During Follow-Up
Total number of bronchiectasis exacerbations recorded for each participant during the 12-month follow-up period. Higher exacerbation count indicates greater disease instability and worse clinical outcome. Unit of Measure: Number of events.
Measured: Baseline to 12 months follow-up.
Severe Bronchiectasis Exacerbation Requiring Hospitalization
Occurrence of at least one bronchiectasis exacerbation requiring hospital admission during the 12-month follow-up period. Hospitalization-requiring exacerbation indicates more severe clinical deterioration and worse outcome. Unit of Measure: Percentage of participants.
Measured: Baseline to 12 months follow-up.
Change in Forced Expiratory Volume in One Second Percent Predicted (FEV1% Predicted)
Change in forced expiratory volume in one second percent predicted (FEV1% predicted) measured by spirometry from baseline to 12 months. Change will be calculated as the 12-month value minus the baseline value. Lower or declining FEV1% predicted indicates worsening airflow limitation and worse functional outcome. Unit of Measure: Percentage points.
Measured: Baseline to 12 months follow-up.
Change in Resting Room-Air Oxygen Saturation Measured by Pulse Oximetry (SpO₂)
Change in resting room-air oxygen saturation measured by pulse oximetry (SpO₂) from baseline to 12 months, when clinically feasible. Change will be calculated as the 12-month value minus the baseline value. Lower or declining SpO₂ indicates worse oxygenation reserve. Unit of Measure: Percentage points.
Measured: Baseline to 12 months follow-up.
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Change in neutrophil-to-lymphocyte ratio (NLR), calculated from complete blood count as absolute neutrophil count divided by absolute lymphocyte count, from baseline to 12 months. Higher or increasing NLR indicates greater systemic neutrophilic inflammatory activity. Unit of Measure: Unitless ratio.
Measured: Baseline to 12 months follow-up.
Change in C-Reactive Protein (CRP)
Change in C-reactive protein (CRP) from baseline to 12 months using routine laboratory measurement. Change will be calculated as the 12-month value minus the baseline value. Higher or increasing CRP indicates greater systemic inflammatory activity. Unit of Measure: Milligrams per liter (mg/L).
Measured: Baseline to 12 months follow-up.
Bronchiectasis-Related Hospital Admission
Occurrence of hospital admission related to bronchiectasis deterioration, respiratory infection, bronchiectasis exacerbation, worsening respiratory symptoms, or related respiratory failure during follow-up. Occurrence of bronchiectasis-related hospital admission indicates worse clinical outcome. Unit of Measure: Percentage of participants.
Measured: Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the Bronchiectasis Severity Index (BSI)
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework with the Bronchiectasis Severity Index (BSI) for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Higher discrimination and better calibration indicate better predictive performance. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Measured: Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the FACED Score
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework with the FACED score for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Higher discrimination and better calibration indicate better predictive performance. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Measured: Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the E-FACED Score
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework with the E-FACED score for prediction of 12-month bronchiectasis exacerbation outcomes where complete data are available. Higher discrimination and better calibration indicate better predictive performance. Unit of Measure: Area under the receiver operating characteristic curve (0-1 scale).
Measured: Baseline to 12 months follow-up.
Change in Modified Reiff Score
Change in Modified Reiff score from baseline to 12 months. The Modified Reiff score assesses radiological bronchiectasis extent and bronchial dilatation severity across six lobes, including the lingula, with a total score ranging from 0 to 18. Change will be calculated as the 12-month value minus the baseline value. Higher or increasing Modified Reiff score indicates greater structural radiological bronchiectasis burden or progression. Unit of Measure: Points.
Measured: Baseline to 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start11 Sep 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M Shaddad, MD, Principal investigator, Assiut UniversityAliae A. Hussien, MD, Principal investigator, Assiut UniversityMaiada K. Hashem, MD, Principal investigator, Assiut UniversityAlaa Sayed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599839
- Sponsor's protocol ID
- 2026-37-5
- Other IDs
- 10.5281/zenodo.20143505
- Acronym
- BASE
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be made available only upon reasonable scientific request and after approval by the principal investigator, the institutional authority, and the relevant ethics committee when applicable. Data sharing will be restricted to approved research purposes and will require a formal data use agreement. No directly identifiable participant information will be shared. The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework, scoring architecture, analytic code, model coefficients, and related intellectual materials remain under the authority of the investigators and Assiut University unless separately released by formal written authorization.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASE: Bronchiectasis Assessment of Severity and Exacerbations for Baseline Severity Classification and One-Year Exacerbation Risk Prediction in Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT07599839
- Acronym / sponsor ID
- BASE / 2026-37-5
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic airway disease characterized by permanent bronchial dilatation, impaired mucociliary clearance, recurrent infection, persistent airway inflammation, and repeated exacerbations. Disease severity and future exacerbation risk are heterogeneous among patients, and accurate baseline risk stratification remains clinically important for follow-up planning, preventive strategies, and early identification of patients at higher risk of clinical deterioration.
Existing bronchiectasis severity tools provide useful clinical stratification, but several established approaches include variables such as previous exacerbation history, previous hospitalization, subjective dyspnea assessment, or culture-based microbiological classification. These variables may be influenced by health-care access, documentation quality, patient perception, physician decision thresholds, sputum sampling quality, timing of culture, and prior antibiotic exposure. Therefore, there is a need to evaluate whether a focused objective disease-signature framework can classify current disease severity and predict future exacerbation risk using baseline functional, radiological, oxygenation, and inflammatory variables.
The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework is designed as a baseline clinical assessment model for adults with non-cystic fibrosis bronchiectasis (NCFB). The 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 bronchiectasis exacerbation risk. Detailed variable definitions, scoring rules, point-conversion methods, endpoint hierarchy, development-validation governance, and analytic specifications are archived in a restricted-access Zenodo record before final model derivation and validation: https://doi.org/10.5281/zenodo.20143505
.
This is a prospective observational cohort study. Participants will not be assigned to any treatment or intervention by the study protocol. All clinical management decisions, including airway clearance, antibiotic treatment, inhaled therapy, microbiological testing, follow-up frequency, and hospitalization decisions, will follow routine clinical care and institutional practice.
Eligible participants will undergo baseline clinical assessment, pulmonary function assessment, chest imaging review, resting room-air oxygenation assessment, and inflammatory marker assessment. Follow-up will continue for 12 months. During follow-up, bronchiectasis exacerbations, severe exacerbations requiring hospitalization, lung-function change, inflammatory marker change, treatment escalation, and clinical outcomes will be recorded using structured data collection forms.
The study will use a development-validation design. The BASE-S and BASE-P equations, point structures, severity categories, and risk bands will be derived in the development cohort. The final locked models will then be applied unchanged to the validation cohort. No refitting, recalibration, variable substitution, point-score modification, or threshold retuning will be performed in the validation cohort. Model performance will be assessed using discrimination, calibration, risk-band separation, clinical utility where applicable, and comparison with established bronchiectasis severity tools where complete data are available.
The intended output is a practical baseline disease-signature framework that can support severity classification and one-year exacerbation-risk prediction in adults with non-cystic fibrosis bronchiectasis (NCFB), while preserving separation from any future interventional treatment studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Twelve-Month Bronchiectasis Exacerbation Risk Predicted by the BASE Prognostic Model (BASE-P)
Time frame: 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.
13 secondary outcomes
Current Bronchiectasis Severity Classification by the BASE Severity Model (BASE-S)
Time frame: Baseline Day 1
Time to First Bronchiectasis Exacerbation
Time frame: Baseline to 12 months follow-up.
Number of Bronchiectasis Exacerbations During Follow-Up
Time frame: Baseline to 12 months follow-up.
Severe Bronchiectasis Exacerbation Requiring Hospitalization
Time frame: Baseline to 12 months follow-up.
Change in Forced Expiratory Volume in One Second Percent Predicted (FEV1% Predicted)
Time frame: Baseline to 12 months follow-up.
Change in Resting Room-Air Oxygen Saturation Measured by Pulse Oximetry (SpO₂)
Time frame: Baseline to 12 months follow-up.
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Baseline to 12 months follow-up.
Change in C-Reactive Protein (CRP)
Time frame: Baseline to 12 months follow-up.
Bronchiectasis-Related Hospital Admission
Time frame: Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the Bronchiectasis Severity Index (BSI)
Time frame: Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the FACED Score
Time frame: Baseline to 12 months follow-up.
Comparison of the Bronchiectasis Assessment of Severity and Exacerbations (BASE) Framework With the E-FACED Score
Time frame: Baseline to 12 months follow-up.
Change in Modified Reiff Score
Time frame: Baseline to 12 months follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be made available only upon reasonable scientific request and after approval by the principal investigator, the institutional authority, and the relevant ethics committee when applicable. Data sharing will be restricted to approved research purposes and will require a formal data use agreement. No directly identifiable participant information will be shared. The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework, scoring architecture, analytic code, model coefficients, and related intellectual materials remain under the authority of the investigators and Assiut University unless separately released by formal written authorization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad M Shaddad, MD principal investigator
Assiut University
Aliae A. Hussien, MD principal investigator
Assiut University
Maiada K. Hashem, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Non-cystic Fibrosis Bronchiectasis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M Shaddad, MD (+201111171930, shaddad_ahmad@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twelve-Month Bronchiectasis Exacerbation Risk Predicted by the BASE Prognostic Model (BASE-P) (time frame: Baseline to 12 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.