The Clinical Significance of CT-based Biomarkers in the Classification and Prognosis of Bronchiectasis

August 13, 2025 updated by: Wang xiaorong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Bronchiectasis is a common lung disease with a high incidence and low attention rate, and the imaging of bronchiectasis is characterized by diverse sites of involvement, morphological features and airway obstruction, as well as different clinical symptoms, severity and prognosis, and response to treatment. Therefore, how to establish a personalized prognostic evaluation system has also become a current research hotspot.

It has been demonstrated that chronic sputum aggregation or destruction of the airway wall leads to the appearance of emphysema, mucus plugs, and pulmonary solid changes in the lung parenchyma adjacent to the diseased bronchus. Emphysema and bronchiectasis share the same pathogenesis, such as chronic inflammation and alpha-1 trypsin deficiency, etc., and to some extent a vicious circle of mutual exacerbation. Thus subjects with coexisting emphysema tend to have a higher likelihood of infection compared to subjects with bronchiectasis without manifestations of emphysema. Emphysema is also recognized as an independent risk factor for 5-year mortality in patients with bronchiectasis. Meanwhile, high mucus secretion, another major manifestation in patients with bronchiectasis, which may be visualized on imaging as the formation of mucus plugs or dendritic signs, is a contributing factor to chronic obstruction in bronchiectasis and also appears to be the best predictor of mortality in patients with bronchiectasis. It can be concluded that different imaging manifestations in patients with bronchiectasis are closely related to clinical manifestations and prognosis. In this study, we attempted to establish a new assessment system of imaging severity by analyzing the imaging manifestations of patients with bronchiectasis and conducting a 3-year follow-up of the patients with bronchiectasis to further understand the clinical significance of imaging in the staging of bronchiectasis and the prognosis of the disease.

According to the inclusion and exclusion criteria, patients with confirmed diagnosis of bronchiectasis attending Union Hospital of Tongji Medical College, Huazhong University of Science and Technology between March 31, 2024 and March 31, 2027 were included in this study. At the time of enrollment, the researchers collected the subjects' demographic information, such as gender, age, height (m), weight (kg), clinical symptoms, such as cough, sputum, hemoptysis, dyspnea, blood test results, such as red blood cell count (10^12/L), hemoglobin (g/L), white blood cells (10^9/L), CRP (mg/L), sputum culture, and lung function test results, such as FVC (L), FVC (L), FVC (L), FVC (L), FVC (L), CRP (M), FVC (L), and sputum culture. , such as FVC (L), FEV1 (L), FEV1/FVC (%), and lung imaging (CT, etc.), such as type of bronchiectasis; degree of bronchiectasis, number of lung segments involved, grade of lung segments involved, and thickness of tubular wall; site of emphysema, its severity, number of segments involved, and its typology; site of mucus plugs, number of lung segments involved; lung abscesses; lung solids; and lung macroglossia.

Through the collection of the above data, the investigators will score the imaging and clinical manifestations of the patients, such as Bhalla score, Reiff score, BSI, FACED, emphysema grading, mucus plug score, etc. The subjects were also followed up every six months for three years after enrollment to obtain the number of acute exacerbations, number of hospitalizations, and patient survival per year in order to derive the relationship between imaging manifestations and prognosis and staging of bronchiectasis.

METHODS: In this study, blood, sputum, lung function and lung CT results were collected from the subjects during their normal visit to the clinic without any intervention and without any additional tests performed by the subjects. Where lung CT scores were scored according to Bhalla scoring criteria, Reiff scoring criteria respectively and scored by two medical imaging physicians.

Emphysema：The distribution of emphysema can be determined by a radiologist's qualitative, visual assessment of the scanned image or quantitatively by CT imaging.The Fleischner Society has standardized the description of visually determined emphysema patterns. Specific software is available that automatically identifies the lungs, traces their contours, and determines a histogram of lung attenuation values that can be used to distinguish between non-emphysematous and emphysematous lung tissue. In healthy lungs, attenuation values are most often distributed between -750 and -850 HU, with an average attenuation of -789 HU. Negative values for emphysema on CT are usually expressed as a percentage of low attenuation areas below a given threshold, with larger values indicating more emphysema. Below -910 HU, -950 HU, and -960 HU are usually considered to be associated with pathologic emphysema. The first value is the most accepted to define mild emphysema, while the last two can be used to define severe emphysema. Large non-AATD COPD clinical studies such as COPDGene (COPD Genetic Epidemiology), SPIROMICS (Subgroups and Intermediate Outcome Indicators in COPD Studies), and ECLIPSE (Longitudinal Evaluation of COPD to Determine Predictive Surrogate Endpoints) have mostly used -950 HU as their threshold for defining emphysema. Therefore, 950 HU was used as the threshold for emphysema in this study.

Mucus plug score：The score is based on counting the number of lung segments with mucus plugs completely blocking middle-to-large-sized airways (i.e., -2-10 mm-lumen diameter) on computed tomography scans. Readers recorded the number of lung segments with mucus plugs in each lobe, with the lingula as a separate lobe. The score ranges from O (no mucus plugs seen in any lung segments) to 18 (all lung segments with mucus plugs). The employed bronchial nomenclature consists of 18 lung segments (right lung: 3, 2, and 5 lung segments in the upper, middle, and lower lobes, respectively; left lung: 2, 2, and 4 lung segments in the upper lobe,lingula, and lower lobe, respectively).

Statistical analysis and statistical methods: The data obtained during the study period were pre-organized. For continuous data, normality test was first executed. If all groups conformed to the normality values, the Student's t-test was used for comparison between groups. Otherwise, nonparametric Wilcoxon rank sum test was considered. For categorical variables, the χ2 test was used. Multifactor logistic regression analysis was performed for statistically significant data. The effect of different nutritional status on the prognosis of subjects with bronchiectasis was analyzed using the subject work characteristics (ROC) and Delong's method, and the difference was statistically significant at P<0.05.

Statistical analysis of all data was performed by SPSS (IBM SPSS Statistics 26.0, SPSS Inc., Chicago, IL) and R language (version 4.1.3, www.R-project.org/). All statistical tests were two-sided and statistical significance was set at 0.05.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with lung Computed Tomography findings and clinical symptoms consistent with bronchiectasis.

Description

Inclusion Criteria:

  • Age 18 years and above;
  • Can cooperate with CT scan;
  • Bronchiectasis confirmed by high-resolution computed tomography of the lungs;
  • Can provide written informed consent

Exclusion Criteria:

  • Pulmonary surgery;
  • Patients with lung cancer, asthma and other respiratory diseases;
  • Tractive bronchiectasis caused by pulmonary fibrosis;
  • Patients with malignant tumors or serious dysfunction of the heart, brain, kidney and other important systems can not cooperate with the completion of this study；
  • Lack of important clinical information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of acute exacerbations of bronchiectasis
Time Frame: From the start of inclusion to one year later.
Acute exacerbations of bronchiectasis were defined according to the consensus published in the European Journal of Respiratory Sciences in 2017, and the frequency of acute exacerbations per year was obtained from participants through follow-up visits.
From the start of inclusion to one year later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deterioration of lung function
Time Frame: From the start of inclusion to one year later.
Participants obtained FEV1 as a percentage of predicted value from pulmonary function tests and scored pulmonary function according to the Bronchiectasis Severity Scale on a scale of 0-2, with higher scores representing poorer lung function.
From the start of inclusion to one year later.
Severity of dyspnoea
Time Frame: From the start of inclusion to one year later.
Dyspnoea was graded according to Modification of the UK Medical Research Council Dyspnoea Scale (mMRC), ranging from 0-IV, with higher grades being associated with more severe dyspnoea.
From the start of inclusion to one year later.
Degree of emphysema
Time Frame: From the start of inclusion to one year later.
Define -950 HU as the threshold for emphysema, with a greater percentage less than -950 HU indicating more emphysema.
From the start of inclusion to one year later.
Mucus plug score
Time Frame: From the start of inclusion to one year later.
The score is based on counting the number of lung segments with mucus plugs completely blocking middle-to-large-sized airways on computed tomography scans. Readers recorded the number of lung segments with mucus plugs in each lobe, with the lingula as a separate lobe. The score ranges from 0 (no mucus plugs seen in any lung segments) to 18 (all lung segments with mucus plugs). The higher the score, the more severe the mucus plug was considered to be.
From the start of inclusion to one year later.
Bhalla scores on CT of participants' lungs
Time Frame: From the start of inclusion to one year later.
A Bhalla severity score was performed and recorded on lung CT at enrolment and during annual follow-up. The Bhalla score is 0-25, with higher scores indicating greater severity.
From the start of inclusion to one year later.
Frequency of hospitalisation
Time Frame: From the start of inclusion to one year later.
Frequency of hospitalisation for bronchiectasis among participants in a year.
From the start of inclusion to one year later.
Death
Time Frame: From the start of inclusion to one year later.
Participants died during follow-up because of bronchiectasis as the main cause of death.
From the start of inclusion to one year later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Xiaorong Wang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2024

Primary Completion (Estimated)

March 26, 2027

Study Completion (Estimated)

March 26, 2027

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024WHXH001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In this study, we will share parts of the study design such as Study Protocol, Statistical Analysis Plan (SAP) and Informed Consent Form (ICF).

IPD Sharing Time Frame

We will share the data 6 months after the end of the study, which lasts for 3 years

IPD Sharing Access Criteria

Data were obtained through the Principal Investigator of this study upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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