BronchiectasisBPIMNCT07599969
Bronchiectasis Phenotype Identification Model
An observational study of Bronchiectasis and Non-cystic Fibrosis Bronchiectasis, run by Assiut University at 1 site in Egypt.
Trial summary
The Bronchiectasis Phenotype Identification Model (BPIM) is a prospective observational development-validation study within the Assiut University bronchiectasis translational research platform. 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 Dec 2026
- 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 clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the enrollment period will be prospectively screened. Eligible participants will undergo baseline disease-signature assessment within the Bronchiectasis Phenotype Identification Model (BPIM) framework and planned longitudinal follow-up for latent class trajectory analysis (LCTA), supervised BPIM classifier development, and validation. Participants receive routine clinical care; no treatment or intervention is assigned by the 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).
- Patients attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period.
- Patients suitable for baseline disease-signature assessment within the Bronchiectasis Phenotype Identification Model (BPIM) framework.
- Ability to undergo routine clinical, functional, radiological, oxygenation, and inflammatory assessment according to the study protocol.
- Ability to complete planned longitudinal follow-up required for latent class trajectory analysis (LCTA) and Bronchiectasis Phenotype Identification Model (BPIM) validation.
- 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 planned follow-up.
- Acute life-threatening illness preventing safe enrollment or reliable baseline assessment.
Show all 10Show fewer
- Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment.
- Inability to complete required baseline disease-signature assessment according to the Bronchiectasis Phenotype Identification Model (BPIM) protocol.
- Inability or unwillingness to complete planned longitudinal 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, Assiut Egypt, 71515
Ahmad M Shaddad, MD, +201111171930, shaddad_ahmad@aun.edu.eg
About this study
Official title: BPIM: Bronchiectasis Phenotype Identification Model for Supervised Baseline Translation of Latent Class Trajectory Analysis-Derived Phenotypes in Non-Cystic Fibrosis Bronchiectasis
The Bronchiectasis Phenotype Identification Model (BPIM) is a prospective observational development-validation study within the Assiut University bronchiectasis translational research platform.
The study evaluates whether latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes can be translated into a supervised baseline classifier for adults with non-cystic fibrosis bronchiectasis (NCFB).
Read more
Latent class trajectory analysis (LCTA) will first identify trajectory-derived phenotype classes using prospectively collected longitudinal disease-signature data. The Bronchiectasis Phenotype Identification Model (BPIM) will then be trained to predict the accepted latent class trajectory analysis (LCTA)-derived phenotype class using the locked baseline disease-signature architecture.
This study is observational and non-interventional. No treatment, medication, intervention, exposure, or management strategy is assigned by the protocol. All participants receive routine clinical care according to institutional practice and treating physician judgment.
The locked methodological disclosure, protocol, and deterministic statistical analysis plan are archived in the version-specific Zenodo record: https://doi.org/10.5281/zenodo.20157926.
Read the detailed description
The Bronchiectasis Phenotype Identification Model (BPIM) is developed within the Assiut University prospective bronchiectasis translational research platform as a supervised baseline phenotype-translation framework for adults with non-cystic fibrosis bronchiectasis (NCFB).
The Bronchiectasis Phenotype Identification Model (BPIM) follows a two-step analytical architecture. First, latent class trajectory analysis (LCTA) identifies trajectory-derived bronchiectasis phenotype classes using prospectively collected longitudinal disease-signature data. Second, the Bronchiectasis Phenotype Identification Model (BPIM) translates the accepted latent class trajectory analysis (LCTA)-derived phenotype structure into a supervised baseline classifier using the locked baseline disease-signature architecture.
The Bronchiectasis Phenotype Identification Model (BPIM) is methodologically separated from the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework while remaining scientifically linked to it. The Bronchiectasis Assessment of Severity and Exacerbations Severity model (BASE-S) classifies current bronchiectasis severity at baseline. The Bronchiectasis Assessment of Severity and Exacerbations Prognostic model (BASE-P) predicts 12-month bronchiectasis exacerbation risk. The Bronchiectasis Phenotype Identification Model (BPIM) predicts the accepted latent class trajectory analysis (LCTA)-derived phenotype class.
The study uses a prospective observational development-validation design. The development cohort will be used to execute the prespecified latent class trajectory analysis (LCTA) hierarchy, identify the accepted trajectory-derived phenotype structure, assign phenotype labels according to the locked convention, and train the supervised Bronchiectasis Phenotype Identification Model (BPIM) classifier. The validation cohort will be used only to evaluate the locked Bronchiectasis Phenotype Identification Model (BPIM) classifier without refitting, recalibration, predictor substitution, phenotype relabeling, threshold retuning, or post hoc classifier rescue.
The latent class trajectory analysis (LCTA) component will use a prespecified top-down variable-combination hierarchy based on longitudinal functional, oxygenation, and inflammatory disease-signature domains. Three-domain latent class trajectory analysis (LCTA) options will be attempted first. If no acceptable three-domain solution is identified, two-domain options will be attempted. If all three-domain and two-domain options fail, one-domain options will be attempted as the final fallback level. Class-number selection, acceptability criteria, failure criteria, and phenotype-labeling rules are prespecified in the locked protocol and statistical analysis plan.
Following acceptance of the latent class trajectory analysis (LCTA) solution, phenotype classes will be ordered according to increasing composite inflammatory and functional disease burden. Depending on the accepted class number, phenotype labels may include Stable phenotype, Progressive/Frequent Exacerbator phenotype, Frequent Exacerbator/Inflammatory phenotype, Advanced Multidomain phenotype, and End-stage/Terminal-risk phenotype according to the locked labeling convention.
The Bronchiectasis Phenotype Identification Model (BPIM) classifier will be trained as a supervised baseline classifier. Binary logistic regression will be used if the accepted latent class trajectory analysis (LCTA) solution contains two classes. Multinomial logistic regression will be used if the accepted latent class trajectory analysis (LCTA) solution contains three or four classes. Classification performance will be evaluated using confusion matrix, overall accuracy, class-specific sensitivity, class-specific specificity, positive predictive value, negative predictive value, macro-average F1 score where applicable, and agreement between predicted Bronchiectasis Phenotype Identification Model (BPIM) class and accepted latent class trajectory analysis (LCTA)-derived class. Where predicted class probabilities are generated, probability calibration will be assessed using calibration plots, observed-versus-predicted class probability summaries, and calibration metrics where appropriate.
The Bronchiectasis Phenotype Identification Model (BPIM) study is observational and non-interventional. No treatment, medication, intervention, exposure, or management strategy is assigned by this protocol. All clinical care follows routine institutional practice and treating physician judgment. The study is not designed to estimate causal treatment effects.
The locked methodological disclosure, protocol, deterministic statistical analysis plan, latent class trajectory analysis (LCTA) variable ledger, phenotype-labeling convention, supervised classifier structure, and validation governance are archived in the version-specific Zenodo record: https://doi.org/10.5281/zenodo.20157926.
The related Bronchiectasis Assessment of Severity and Exacerbations (BASE) structural lock is archived separately at: https://doi.org/10.5281/zenodo.20143505.
- Conditions
- Bronchiectasis, Non-cystic Fibrosis Bronchiectasis, Bronchiectasis With Acute Exacerbation
- Keywords
- Non-cystic fibrosis bronchiectasis (NCFB), Bronchiectasis, Bronchiectasis Phenotype Identification Model (BPIM), Bronchiectasis exacerbation, Exacerbation risk, One-year exacerbation risk, Baseline risk prediction, Disease-signature model, Prospective observational cohort, Development-validation study, Latent class trajectory analysis (LCTA), supervised phenotype classifier
- 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 clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) assigned to the analytical development cohort. This cohort will be used to execute the prespecified latent class trajectory analysis (LCTA) hierarchy, identify the accepted trajectory-derived phenotype structure, assign phenotype labels according to the locked convention, and train the supervised Bronchiectasis Phenotype Identification Model (BPIM) classifier using the locked baseline disease-signature architecture. No treatment, medication, intervention, exposure, or management strategy is assigned by the study protocol. | |
| Validation Cohort | Adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) assigned to the analytical validation cohort. This cohort will be used only to evaluate the locked Bronchiectasis Phenotype Identification Model (BPIM) classifier after training in the development cohort. No validation-stage refitting, recalibration, predictor substitution, phenotype relabeling, threshold retuning, or post hoc classifier rescue will be performed. No treatment, medication, intervention, exposure, or management strategy is assigned by the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation Classification Accuracy of the Bronchiectasis Phenotype Identification Model (BPIM) for Latent Class Trajectory Analysis-Derived Phenotype Classes
Assessment of the validation performance of the Bronchiectasis Phenotype Identification Model (BPIM) for prediction of accepted latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes in adults with non-cystic fibrosis bronchiectasis (NCFB). The Bronchiectasis Phenotype Identification Model (BPIM) is a supervised baseline phenotype classifier trained in the development cohort and applied unchanged to the validation cohort. The accepted latent class trajectory analysis (LCTA)-derived phenotype class will serve as the phenotype ground truth. Higher classification accuracy indicates better agreement between Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class and accepted latent class trajectory analysis (LCTA)-derived phenotype class. Unit of Measure: Percentage of participants correctly classified.
Measured: Baseline to 12 months follow-up.
Secondary outcomes (16)
Accepted Latent Class Trajectory Analysis-Derived Phenotype Class
Identification of the accepted latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype class using prospectively collected longitudinal disease-signature data. Latent class trajectory analysis (LCTA) will use prespecified functional, oxygenation, and inflammatory longitudinal domains according to the locked variable-combination hierarchy. Depending on the accepted class-number solution, phenotype classes may include Stable phenotype, Progressive/Frequent Exacerbator phenotype, Frequent Exacerbator/Inflammatory phenotype, Advanced Multidomain phenotype, and End-stage/Terminal-risk phenotype according to the locked labeling convention. Unit of Measure: Percentage of participants in each phenotype class.
Measured: Baseline to 12 months follow-up.
Agreement Between Bronchiectasis Phenotype Identification Model-Predicted Class and Accepted Latent Class Trajectory Analysis-Derived Class
Agreement between Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class and accepted latent class trajectory analysis (LCTA)-derived phenotype class. Agreement may be assessed using agreement statistics appropriate to the accepted class structure. Higher agreement indicates better reproducibility of latent class trajectory analysis (LCTA)-derived phenotype classes using the supervised Bronchiectasis Phenotype Identification Model (BPIM) baseline classifier. Unit of Measure: Kappa coefficient
Measured: Baseline to 12 months follow-up.
Class-Specific Sensitivity of the Bronchiectasis Phenotype Identification Model
Assessment of class-specific sensitivity of the Bronchiectasis Phenotype Identification Model (BPIM) for each accepted latent class trajectory analysis (LCTA)-derived phenotype class. Sensitivity represents the proportion of participants in a given accepted phenotype class who are correctly classified by Bronchiectasis Phenotype Identification Model (BPIM) into that same class. Higher values indicate better class-specific recognition. Unit of Measure: Percentage.
Measured: Baseline to 12 months follow-up.
Class-Specific Specificity of the Bronchiectasis Phenotype Identification Model
Assessment of class-specific specificity of the Bronchiectasis Phenotype Identification Model (BPIM) for each accepted latent class trajectory analysis (LCTA)-derived phenotype class. Specificity represents the proportion of participants not belonging to a given phenotype class who are correctly classified by Bronchiectasis Phenotype Identification Model (BPIM) as not belonging to that class. Higher values indicate better class-specific exclusion. Unit of Measure: Percentage.
Measured: Baseline to 12 months follow-up.
Positive Predictive Value of the Bronchiectasis Phenotype Identification Model for Phenotype Classification
Assessment of positive predictive value for each Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class. Positive predictive value represents the proportion of participants predicted by Bronchiectasis Phenotype Identification Model (BPIM) to belong to a given phenotype class who truly belong to the accepted latent class trajectory analysis (LCTA)-derived class. Higher values indicate better precision of phenotype assignment. Unit of Measure: Percentage.
Measured: Baseline to 12 months follow-up.
Negative Predictive Value of the Bronchiectasis Phenotype Identification Model for Phenotype Classification
Assessment of negative predictive value for each Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class. Negative predictive value represents the proportion of participants not predicted by Bronchiectasis Phenotype Identification Model (BPIM) to belong to a given phenotype class who truly do not belong to that accepted latent class trajectory analysis (LCTA)-derived class. Higher values indicate better exclusion of phenotype membership. Unit of Measure: Percentage.
Measured: Baseline to 12 months follow-up.
Macro-Average F1 Score of the Bronchiectasis Phenotype Identification Model
Assessment of macro-average F1 score for Bronchiectasis Phenotype Identification Model (BPIM) phenotype classification. Macro-average F1 score summarizes balanced classifier performance across accepted phenotype classes by combining class-specific precision and recall while giving each class equal weight. Higher values indicate better balanced multiclass classification performance. Unit of Measure: F1 score, 0 to 1 scale.
Measured: Baseline to 12 months follow-up.
Probability Calibration of the Bronchiectasis Phenotype Identification Model
Assessment of calibration of Bronchiectasis Phenotype Identification Model (BPIM)-predicted class probabilities where predicted phenotype probabilities are generated. Calibration will evaluate agreement between predicted class probabilities and observed accepted latent class trajectory analysis (LCTA)-derived phenotype membership. Better calibration indicates closer agreement between predicted probability and observed phenotype membership. Unit of Measure: Calibration slope
Measured: Baseline to 12 months follow-up.
Confusion Matrix of Bronchiectasis Phenotype Identification Model Classification
Confusion matrix comparing Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class with accepted latent class trajectory analysis (LCTA)-derived phenotype class. The confusion matrix will summarize correct and incorrect class assignment across the accepted phenotype classes. Unit of Measure: Percentage of participants
Measured: Baseline to 12 months follow-up.
Relationship Between Bronchiectasis Phenotype Identification Model Phenotype Classes and Bronchiectasis Assessment of Severity and Exacerbations Severity Categories
Assessment of the relationship between accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype classes and Bronchiectasis Assessment of Severity and Exacerbations Severity model (BASE-S) categories. This analysis evaluates whether trajectory-derived phenotype classes show clinically coherent patterns across baseline severity categories. Unit of Measure: Percentage of participants across categories.
Measured: Baseline
Relationship Between Bronchiectasis Phenotype Identification Model Phenotype Classes and Bronchiectasis Assessment of Severity and Exacerbations Prognostic Risk Categories
Assessment of the relationship between accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype classes and Bronchiectasis Assessment of Severity and Exacerbations Prognostic model (BASE-P) risk categories. This analysis evaluates whether trajectory-derived phenotype classes show clinically coherent patterns across 12-month exacerbation-risk categories. Unit of Measure: Percentage of participants across categories.
Measured: Baseline to 12 months follow-up.
Bronchiectasis Exacerbation Occurrence by Bronchiectasis Phenotype Identification Model Phenotype Class
Occurrence of at least one bronchiectasis exacerbation during follow-up according to accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype class. Higher exacerbation occurrence in higher-burden phenotype classes indicates clinically coherent phenotype-outcome association. Unit of Measure: Percentage of participants.
Measured: Baseline to 12 months follow-up.
Time to First Bronchiectasis Exacerbation by Bronchiectasis Phenotype Identification Model Phenotype Class
Time from baseline assessment to first recorded bronchiectasis exacerbation according to accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype class. Participants without exacerbation will be censored at last available follow-up or at 12 months. Shorter time to first exacerbation indicates earlier clinical deterioration. Unit of Measure: Days.
Measured: Baseline to 12 months follow-up.
Number of Bronchiectasis Exacerbations During Follow-Up by Bronchiectasis Phenotype Identification Model Phenotype Class
Total number of bronchiectasis exacerbations during follow-up according to accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype class. Higher exacerbation count indicates greater disease instability. Unit of Measure: Number of events.
Measured: Baseline to 12 months follow-up.
Severe Bronchiectasis Exacerbation Requiring Hospitalization by Bronchiectasis Phenotype Identification Model Phenotype Class
Occurrence of at least one severe bronchiectasis exacerbation requiring hospital admission during follow-up according to accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype class. Hospitalization-requiring exacerbation indicates more severe clinical deterioration. Unit of Measure: Percentage of participants.
Measured: Baseline to 12 months follow-up.
Bronchiectasis-Related Hospital Admission by Bronchiectasis Phenotype Identification Model Phenotype Class
Occurrence of bronchiectasis-related hospital admission during follow-up according to accepted Bronchiectasis Phenotype Identification Model (BPIM) phenotype class. Bronchiectasis-related hospital admission includes admission related to bronchiectasis deterioration, respiratory infection, bronchiectasis exacerbation, worsening respiratory symptoms, or related respiratory failure. Unit of Measure: Percentage of participants.
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 Nov 2026 (estimated)
- Study completion1 Dec 2026 (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 S. Ali, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599969
- Sponsor's protocol ID
- 2026-5-42
- Other IDs
- 10.5281/zenodo.20157926
- Acronym
- BPIM
- 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 shared only upon reasonable scientific request and after approval by the principal investigator, Faculty of Medicine, Assiut University, and the relevant ethics committee when applicable. Data sharing will be restricted to approved scientific purposes related to non-cystic fibrosis bronchiectasis (NCFB), phenotype classification, latent class trajectory analysis (LCTA), or supervised prediction research. No directly identifiable participant data will be shared. The Bronchiectasis Phenotype Identification Model (BPIM) framework, analytical code, model coefficients, calculators, and related intellectual materials remain protected and are not automatically shared with participant data.
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
- BPIM: Bronchiectasis Phenotype Identification Model for Supervised Baseline Translation of Latent Class Trajectory Analysis-Derived Phenotypes in Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT07599969
- Acronym / sponsor ID
- BPIM / 2026-5-42
- Conditions
- Bronchiectasis, Non-cystic Fibrosis Bronchiectasis, Bronchiectasis With Acute Exacerbation
- Keywords
- Non-cystic fibrosis bronchiectasis (NCFB), Bronchiectasis, Bronchiectasis Phenotype Identification Model (BPIM), 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 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (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.
The Bronchiectasis Phenotype Identification Model (BPIM) is a prospective observational development-validation study within the Assiut University bronchiectasis translational research platform.
The study evaluates whether latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes can be translated into a supervised baseline classifier for adults with non-cystic fibrosis bronchiectasis (NCFB).
Latent class trajectory analysis (LCTA) will first identify trajectory-derived phenotype classes using prospectively collected longitudinal disease-signature data. The Bronchiectasis Phenotype Identification Model (BPIM) will then be trained to predict the accepted latent class trajectory analysis (LCTA)-derived phenotype class using the locked baseline disease-signature architecture.
This study is observational and non-interventional. No treatment, medication, intervention, exposure, or management strategy is assigned by the protocol. All participants receive routine clinical care according to institutional practice and treating physician judgment.
The locked methodological disclosure, protocol, and deterministic statistical analysis plan are archived in the version-specific Zenodo record: https://doi.org/10.5281/zenodo.20157926.
Detailed description
The Bronchiectasis Phenotype Identification Model (BPIM) is developed within the Assiut University prospective bronchiectasis translational research platform as a supervised baseline phenotype-translation framework for adults with non-cystic fibrosis bronchiectasis (NCFB).
The Bronchiectasis Phenotype Identification Model (BPIM) follows a two-step analytical architecture. First, latent class trajectory analysis (LCTA) identifies trajectory-derived bronchiectasis phenotype classes using prospectively collected longitudinal disease-signature data. Second, the Bronchiectasis Phenotype Identification Model (BPIM) translates the accepted latent class trajectory analysis (LCTA)-derived phenotype structure into a supervised baseline classifier using the locked baseline disease-signature architecture.
The Bronchiectasis Phenotype Identification Model (BPIM) is methodologically separated from the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework while remaining scientifically linked to it. The Bronchiectasis Assessment of Severity and Exacerbations Severity model (BASE-S) classifies current bronchiectasis severity at baseline. The Bronchiectasis Assessment of Severity and Exacerbations Prognostic model (BASE-P) predicts 12-month bronchiectasis exacerbation risk. The Bronchiectasis Phenotype Identification Model (BPIM) predicts the accepted latent class trajectory analysis (LCTA)-derived phenotype class.
The study uses a prospective observational development-validation design. The development cohort will be used to execute the prespecified latent class trajectory analysis (LCTA) hierarchy, identify the accepted trajectory-derived phenotype structure, assign phenotype labels according to the locked convention, and train the supervised Bronchiectasis Phenotype Identification Model (BPIM) classifier. The validation cohort will be used only to evaluate the locked Bronchiectasis Phenotype Identification Model (BPIM) classifier without refitting, recalibration, predictor substitution, phenotype relabeling, threshold retuning, or post hoc classifier rescue.
The latent class trajectory analysis (LCTA) component will use a prespecified top-down variable-combination hierarchy based on longitudinal functional, oxygenation, and inflammatory disease-signature domains. Three-domain latent class trajectory analysis (LCTA) options will be attempted first. If no acceptable three-domain solution is identified, two-domain options will be attempted. If all three-domain and two-domain options fail, one-domain options will be attempted as the final fallback level. Class-number selection, acceptability criteria, failure criteria, and phenotype-labeling rules are prespecified in the locked protocol and statistical analysis plan.
Following acceptance of the latent class trajectory analysis (LCTA) solution, phenotype classes will be ordered according to increasing composite inflammatory and functional disease burden. Depending on the accepted class number, phenotype labels may include Stable phenotype, Progressive/Frequent Exacerbator phenotype, Frequent Exacerbator/Inflammatory phenotype, Advanced Multidomain phenotype, and End-stage/Terminal-risk phenotype according to the locked labeling convention.
The Bronchiectasis Phenotype Identification Model (BPIM) classifier will be trained as a supervised baseline classifier. Binary logistic regression will be used if the accepted latent class trajectory analysis (LCTA) solution contains two classes. Multinomial logistic regression will be used if the accepted latent class trajectory analysis (LCTA) solution contains three or four classes. Classification performance will be evaluated using confusion matrix, overall accuracy, class-specific sensitivity, class-specific specificity, positive predictive value, negative predictive value, macro-average F1 score where applicable, and agreement between predicted Bronchiectasis Phenotype Identification Model (BPIM) class and accepted latent class trajectory analysis (LCTA)-derived class. Where predicted class probabilities are generated, probability calibration will be assessed using calibration plots, observed-versus-predicted class probability summaries, and calibration metrics where appropriate.
The Bronchiectasis Phenotype Identification Model (BPIM) study is observational and non-interventional. No treatment, medication, intervention, exposure, or management strategy is assigned by this protocol. All clinical care follows routine institutional practice and treating physician judgment. The study is not designed to estimate causal treatment effects.
The locked methodological disclosure, protocol, deterministic statistical analysis plan, latent class trajectory analysis (LCTA) variable ledger, phenotype-labeling convention, supervised classifier structure, and validation governance are archived in the version-specific Zenodo record: https://doi.org/10.5281/zenodo.20157926.
The related Bronchiectasis Assessment of Severity and Exacerbations (BASE) structural lock is archived separately at: https://doi.org/10.5281/zenodo.20143505.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development Cohort | – | –Adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) assigned to the analytical development cohort. This cohort will be used to execute the prespecified latent class trajectory analysis (LCTA) hierarchy, identify the accepted trajectory-derived phenotype structure, assign phenotype labels according to the locked convention, and train the supervised Bronchiectasis Phenotype Identification Model (BPIM) classifier using the locked baseline disease-signature architecture. No treatment, medication, intervention, exposure, or management strategy is assigned by the study protocol. |
| Validation Cohort | – | –Adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) assigned to the analytical validation cohort. This cohort will be used only to evaluate the locked Bronchiectasis Phenotype Identification Model (BPIM) classifier after training in the development cohort. No validation-stage refitting, recalibration, predictor substitution, phenotype relabeling, threshold retuning, or post hoc classifier rescue will be performed. No treatment, medication, intervention, exposure, or management strategy is assigned by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the enrollment period will be prospectively screened. Eligible participants will undergo baseline disease-signature assessment within the Bronchiectasis Phenotype Identification Model (BPIM) framework and planned longitudinal follow-up for latent class trajectory analysis (LCTA), supervised BPIM classifier development, and validation. Participants receive routine clinical care; no treatment or intervention is assigned by the protocol.
Key inclusion criteria (7 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).
- Patients attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period.
- Patients suitable for baseline disease-signature assessment within the Bronchiectasis Phenotype Identification Model (BPIM) framework.
- Ability to undergo routine clinical, functional, radiological, oxygenation, and inflammatory assessment according to the study protocol.
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 planned 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
Validation Classification Accuracy of the Bronchiectasis Phenotype Identification Model (BPIM) for Latent Class Trajectory Analysis-Derived Phenotype Classes
Time frame: Baseline to 12 months follow-up.
Assessment of the validation performance of the Bronchiectasis Phenotype Identification Model (BPIM) for prediction of accepted latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes in adults with non-cystic fibrosis bronchiectasis (NCFB). The Bronchiectasis Phenotype Identification Model (BPIM) is a supervised baseline phenotype classifier trained in the development cohort and applied unchanged to the validation cohort. The accepted latent class trajectory analysis (LCTA)-derived phenotype class will serve as the phenotype ground truth. Higher classification accuracy indicates better agreement between Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class and accepted latent class trajectory analysis (LCTA)-derived phenotype class. Unit of Measure: Percentage of participants correctly classified.
16 secondary outcomes
Accepted Latent Class Trajectory Analysis-Derived Phenotype Class
Time frame: Baseline to 12 months follow-up.
Agreement Between Bronchiectasis Phenotype Identification Model-Predicted Class and Accepted Latent Class Trajectory Analysis-Derived Class
Time frame: Baseline to 12 months follow-up.
Class-Specific Sensitivity of the Bronchiectasis Phenotype Identification Model
Time frame: Baseline to 12 months follow-up.
Class-Specific Specificity of the Bronchiectasis Phenotype Identification Model
Time frame: Baseline to 12 months follow-up.
Positive Predictive Value of the Bronchiectasis Phenotype Identification Model for Phenotype Classification
Time frame: Baseline to 12 months follow-up.
Negative Predictive Value of the Bronchiectasis Phenotype Identification Model for Phenotype Classification
Time frame: Baseline to 12 months follow-up.
Macro-Average F1 Score of the Bronchiectasis Phenotype Identification Model
Time frame: Baseline to 12 months follow-up.
Probability Calibration of the Bronchiectasis Phenotype Identification Model
Time frame: Baseline to 12 months follow-up.
Confusion Matrix of Bronchiectasis Phenotype Identification Model Classification
Time frame: Baseline to 12 months follow-up.
Relationship Between Bronchiectasis Phenotype Identification Model Phenotype Classes and Bronchiectasis Assessment of Severity and Exacerbations Severity Categories
Time frame: Baseline
Relationship Between Bronchiectasis Phenotype Identification Model Phenotype Classes and Bronchiectasis Assessment of Severity and Exacerbations Prognostic Risk Categories
Time frame: Baseline to 12 months follow-up.
Bronchiectasis Exacerbation Occurrence by Bronchiectasis Phenotype Identification Model Phenotype Class
Time frame: Baseline to 12 months follow-up.
Time to First Bronchiectasis Exacerbation by Bronchiectasis Phenotype Identification Model Phenotype Class
Time frame: Baseline to 12 months follow-up.
Number of Bronchiectasis Exacerbations During Follow-Up by Bronchiectasis Phenotype Identification Model Phenotype Class
Time frame: Baseline to 12 months follow-up.
Severe Bronchiectasis Exacerbation Requiring Hospitalization by Bronchiectasis Phenotype Identification Model Phenotype Class
Time frame: Baseline to 12 months follow-up.
Bronchiectasis-Related Hospital Admission by Bronchiectasis Phenotype Identification Model Phenotype Class
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 BPIM Version 1.0 methodological archive including protocol, statistical analysis plan, latent class trajectory analysis variable ledger, phenotype-labeling convention, supervised classifier structure, and validation governance.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared only upon reasonable scientific request and after approval by the principal investigator, Faculty of Medicine, Assiut University, and the relevant ethics committee when applicable. Data sharing will be restricted to approved scientific purposes related to non-cystic fibrosis bronchiectasis (NCFB), phenotype classification, latent class trajectory analysis (LCTA), or supervised prediction research. No directly identifiable participant data will be shared. The Bronchiectasis Phenotype Identification Model (BPIM) framework, analytical code, model coefficients, calculators, and related intellectual materials remain protected and are not automatically shared with participant data.
Related trials for Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
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 7 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?
Validation Classification Accuracy of the Bronchiectasis Phenotype Identification Model (BPIM) for Latent Class Trajectory Analysis-Derived Phenotype Classes (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.