Chronic Obstructive Pulmonary DiseaseNCT07809399
Volumetric HRCT in Stable COPD Patients.
An observational study of Chronic Obstructive Pulmonary Disease and Pulmonary Emphysema, run by Mansoura University at 1 site in Egypt.
Trial summary
This study evaluates the role of volumetric high-resolution computed tomography (HRCT) of the chest in assessing patients with stable chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema, Airway Obstruction
- What is being tested?
- Volumetric HRCT chest and Spirometry and Body Plethysmography
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2025to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients attending the smoking clinic and chest disease general clinic at Mansoura University Hospital who have stable COPD confirmed by pulmonary function testing.
Who may be able to join
None listed.
Who cannot join
- Patient in exacerbation defined as change in the patient's baseline dyspnea, cough, and/or sputum beyond normal day-to-day variations within 14 days . (Ko, Fanny W., et al 2016)
- Connective tissue disease .
- Previously diagnosed Interstitial lung disease
- Contraindication to PFT According to ATS (Stanojevic S., et al 2021)
- Recent Myocardial Infarction Within 1 week
- Blood Pressure Instability Severe hypertension or systemic hypotension
Show all 24Show fewer
- Arrhythmias Significant, uncontrolled atrial or ventricular arrhythmias
- Decompensated heart failure
- Pulmonary Circulation Issues: Uncontrolled pulmonary hypertension, acute cor pulmonale, or clinically unstable pulmonary embolism
- History of Syncope Loss of consciousness related to coughing or forced expiration
- Cerebral Aneurysm
- Recent Brain Surgery: Within 4 weeks
- Concussion: Recent concussion with prolonged symptoms
- Eye Surgery: Recent eye surgery within 1 week
- Pneumothorax: Active or untreated pneumothorax Recent Thoracic Surgery: Within 4 weeks Recent Abdominal Surgery: Within 4 weeks Late-Term Pregnancy
- Contraindicatins of 6MWT according to ATS :
- Absolute contraindications
- Unstable Angina Experienced during the previous 1 month.
- Recent Myocardial Infarction : Within the previous 1 month. Relative contraindications
- Resting Tachycardia: Resting heart rate > 120{ bpm}.
- Severe Uncontrolled Hypertension:
- Systolic Blood Pressure > 180{ mmHg}
- Diastolic Blood Pressure > 100{ mmHg}
- Symptomatic/Severe Cardiac Conditions: High-degree atrioventricular (AV) block, hypertrophic cardiomyopathy, or symptomatic severe aortic stenosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital (Chest Disease Department)
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: The Role of Volumetric High-Resolution Computed Tomography (HRCT) of the Chest in the Assessment of Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
This study evaluates the role of volumetric high-resolution computed tomography (HRCT) of the chest in assessing patients with stable chronic obstructive pulmonary disease (COPD). COPD is a heterogeneous lung condition characterized by chronic pulmonary symptoms, structural airway/alveolar changes, and progressive airflow limitation. While spirometry provides a global assessment of lung function, it cannot localize or fully characterize specific structural abnormalities. Volumetric HRCT allows for detailed, quantitative imaging of lung parenchyma, emphysema extent, air trapping, and airway wall thickness. The primary objective of this cross-sectional observational study is to quantify emphysema, air trapping, and bronchial wall thickness in patients with stable COPD and to evaluate the relationship between these volumetric HRCT findings and clinical measures of disease severity. By identifying objective imaging parameters, this study aims to improve patient evaluation, disease staging, and clinical management.
Read the detailed description
Background and Rationale:
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent respiratory symptoms (such as dyspnea, cough, and sputum production) resulting from airway and/or alveolar abnormalities that cause progressive airflow obstruction. While irreversible airflow obstruction (post-bronchodilator FEV1/FVC < 0.70) measured by spirometry confirms the diagnosis, global spirometric tests lack the spatial resolution required to assess regional parenchymal destruction, emphysema distribution, or peripheral air trapping. Volumetric High-Resolution Computed Tomography (HRCT) enables detailed, three-dimensional quantitative assessment of lung parenchyma and structural alterations in COPD.
Study Objectives:
To quantify emphysema extent, air trapping, and airway wall thickness using volumetric HRCT.
To assess the relationship between quantitative volumetric HRCT findings and clinical measures of COPD severity.
Methods and Procedures:
This cross-sectional observational study is conducted at Mansoura University Hospital (smoking clinic and chest disease general clinic) under ethics approval code MS.25.02.3101. Enrolled participants include patients with stable COPD diagnosed according to GOLD guidelines.
All participants undergo the following assessments:
Clinical Evaluation: Comprehensive history taking (symptoms, smoking status), physical examination, and mMRC Dyspnea Scale grading.
Pulmonary Function Testing \& Lung Volumes: Spirometry (FEV1, FVC, FEV1/FVC, MMEF), 6-Minute Walk Test (6MWT), and lung volume measurements (RV, TLC, RV/TLC%).
Laboratory Tests: Complete Blood Count (CBC) with calculation of Neutrophil-to-Lymphocyte Ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR), and Arterial Blood Gas (ABG) analysis.
HRCT Imaging Protocol: Multidetector HRCT (minimum 64-slice, ≤1,5 mm slice thickness, 512x512 matrix) performed during full inspiratory breath-hold (with optional expiratory scanning for air trapping evaluation). Dedicated high-resolution algorithms and window settings are applied to quantify parenchymal and bronchial changes.
nd bronchial changes.
- Being tested
- Volumetric HRCT chest, Spirometry and Body Plethysmography
- Keywords
- Volumetric HRCT, Pulmonary Function Test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric HRCT chestDiagnostic test
Multidetector volumetric high-resolution computed tomography (≥64 slices, ≤1.0 mm slice thickness) performed during full inspiratory breath-hold and full expiratory breath-hold to quantitatively measure emphysema percentage (EM%), air trapping percentage (AT%), wall thickness (WT), wall area (WA) ,WA% and WT%
Spirometry and Body PlethysmographyDiagnostic test
Standardized pulmonary function testing performed according to ATS/ERS standards to measure post-bronchodilator forced expiratory volumes (FEV1, FVC) and static lung volumes (RV/TLC ratio).
| Study group | Role | What they receive |
|---|---|---|
| Stable COPD Patients | Stable Chronic Obstructive Pulmonary Disease (COPD) patients undergoing quantitative volumetric High-Resolution Computed Tomography (HRCT) of the chest to evaluate parameters such as air trapping and lung volumes, combined with clinical assessment including mMRC dyspnea scale scoring and laboratory assessment including Cbc abg Receives: Diagnostic Test: Volumetric HRCT chest; Diagnostic Test: Spirometry and Body Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emphysema Percentage (EM%) Across GOLD Stages
Volumetric CT assessment quantifying the percentage of low-attenuation lung areas below -950 Hounsfield Units (%LAA-950) across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Measured: Baseline
Bronchial Wall Thickness (WT) Across GOLD Stages
Volumetric CT quantitative measurement of airway wall thickness evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4).Unit of measurements millimeter (mm).
Measured: Baseline
Percentage Wall Area (WA%) Across GOLD Stages
Volumetric CT quantitative measurement of bronchial wall area expressed as a percentage of total bronchial cross-sectional area across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Measured: Baseline
Air Trapping Percentage (AT%) Across GOLD Stages
Volumetric CT assessment evaluating the percentage of low-attenuation lung areas on paired expiratory CT scans (%LAA-856 or expiratory/inspiratory ratio) across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Measured: Baseline
Percentage Wall Thickness (WT%) Across GOLD Stages
Volumetric CT quantitative measurement of bronchial wall thickness expressed as a percentage of total bronchial outer diameter evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Measured: Baseline
Absolute Wall Area (WA) Across GOLD Stages
Volumetric CT quantitative measurement of absolute bronchial wall cross-sectional area evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Millimeter (mm)
Measured: Baseline
Secondary outcomes (2)
Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio
Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative CT-derived emphysema percentage (%LAA-950) and post-bronchodilator FEV1/FVC ratio measured by spirometry.
Unit of Measure: Correlation coefficient (r)
Measured: Baseline (same day or within 1 week of HRCT scan)
Correlation Coefficient Between CT Air Trapping Percentage (AT%) and Plethysmographic RV/TLC Ratio
Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative expiratory CT air trapping percentage (%LAA-856) and plethysmographic Residual Volume to Total Lung Capacity ratio (RV/TLC expressed as % predicted).
Unit of Measure: Correlation coefficient (r)
Measured: Baseline (same day or within 1 week of HRCT scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start20 Apr 2025
- Primary completion20 May 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nesreen Shalabi, Principal investigator, Professor of Chest Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809399
- Sponsor's protocol ID
- MS.25.02.3101
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Volumetric High-Resolution Computed Tomography (HRCT) of the Chest in the Assessment of Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07809399
- Acronym / sponsor ID
- MS.25.02.3101
- Keywords
- Volumetric HRCT, Pulmonary Function Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 9 Sep 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.
This study evaluates the role of volumetric high-resolution computed tomography (HRCT) of the chest in assessing patients with stable chronic obstructive pulmonary disease (COPD). COPD is a heterogeneous lung condition characterized by chronic pulmonary symptoms, structural airway/alveolar changes, and progressive airflow limitation. While spirometry provides a global assessment of lung function, it cannot localize or fully characterize specific structural abnormalities. Volumetric HRCT allows for detailed, quantitative imaging of lung parenchyma, emphysema extent, air trapping, and airway wall thickness. The primary objective of this cross-sectional observational study is to quantify emphysema, air trapping, and bronchial wall thickness in patients with stable COPD and to evaluate the relationship between these volumetric HRCT findings and clinical measures of disease severity. By identifying objective imaging parameters, this study aims to improve patient evaluation, disease staging, and clinical management.
Detailed description
Background and Rationale:
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent respiratory symptoms (such as dyspnea, cough, and sputum production) resulting from airway and/or alveolar abnormalities that cause progressive airflow obstruction. While irreversible airflow obstruction (post-bronchodilator FEV1/FVC < 0.70) measured by spirometry confirms the diagnosis, global spirometric tests lack the spatial resolution required to assess regional parenchymal destruction, emphysema distribution, or peripheral air trapping. Volumetric High-Resolution Computed Tomography (HRCT) enables detailed, three-dimensional quantitative assessment of lung parenchyma and structural alterations in COPD.
Study Objectives:
To quantify emphysema extent, air trapping, and airway wall thickness using volumetric HRCT.
To assess the relationship between quantitative volumetric HRCT findings and clinical measures of COPD severity.
Methods and Procedures:
This cross-sectional observational study is conducted at Mansoura University Hospital (smoking clinic and chest disease general clinic) under ethics approval code MS.25.02.3101. Enrolled participants include patients with stable COPD diagnosed according to GOLD guidelines.
All participants undergo the following assessments:
Clinical Evaluation: Comprehensive history taking (symptoms, smoking status), physical examination, and mMRC Dyspnea Scale grading.
Pulmonary Function Testing \& Lung Volumes: Spirometry (FEV1, FVC, FEV1/FVC, MMEF), 6-Minute Walk Test (6MWT), and lung volume measurements (RV, TLC, RV/TLC%).
Laboratory Tests: Complete Blood Count (CBC) with calculation of Neutrophil-to-Lymphocyte Ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR), and Arterial Blood Gas (ABG) analysis.
HRCT Imaging Protocol: Multidetector HRCT (minimum 64-slice, ≤1,5 mm slice thickness, 512x512 matrix) performed during full inspiratory breath-hold (with optional expiratory scanning for air trapping evaluation). Dedicated high-resolution algorithms and window settings are applied to quantify parenchymal and bronchial changes.
nd bronchial changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable COPD Patients | – | Diagnostic Test: Volumetric HRCT chest, Diagnostic Test: Spirometry and Body PlethysmographyStable Chronic Obstructive Pulmonary Disease (COPD) patients undergoing quantitative volumetric High-Resolution Computed Tomography (HRCT) of the chest to evaluate parameters such as air trapping and lung volumes, combined with clinical assessment including mMRC dyspnea scale scoring and laboratory assessment including Cbc abg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients attending the smoking clinic and chest disease general clinic at Mansoura University Hospital who have stable COPD confirmed by pulmonary function testing.
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Patient in exacerbation defined as change in the patient's baseline dyspnea, cough, and/or sputum beyond normal day-to-day variations within 14 days . (Ko, Fanny W., et al 2016)
- Connective tissue disease .
- Previously diagnosed Interstitial lung disease
- Contraindication to PFT According to ATS (Stanojevic S., et al 2021)
- Contraindicatins of 6MWT according to ATS :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric HRCT chestMultidetector volumetric high-resolution computed tomography (≥64 slices, ≤1.0 mm slice thickness) performed during full inspiratory breath-hold and full expiratory breath-hold to quantitatively measure emphysema percentage (EM%), air trapping percentage (AT%), wall thickness (WT), wall area (WA) ,WA% and WT% | Diagnostic test | Stable COPD Patients |
| Spirometry and Body PlethysmographyStandardized pulmonary function testing performed according to ATS/ERS standards to measure post-bronchodilator forced expiratory volumes (FEV1, FVC) and static lung volumes (RV/TLC ratio). | Diagnostic test | Stable COPD Patients |
Primary outcome
Emphysema Percentage (EM%) Across GOLD Stages
Time frame: Baseline
Volumetric CT assessment quantifying the percentage of low-attenuation lung areas below -950 Hounsfield Units (%LAA-950) across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Bronchial Wall Thickness (WT) Across GOLD Stages
Time frame: Baseline
Volumetric CT quantitative measurement of airway wall thickness evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4).Unit of measurements millimeter (mm).
Percentage Wall Area (WA%) Across GOLD Stages
Time frame: Baseline
Volumetric CT quantitative measurement of bronchial wall area expressed as a percentage of total bronchial cross-sectional area across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Air Trapping Percentage (AT%) Across GOLD Stages
Time frame: Baseline
Volumetric CT assessment evaluating the percentage of low-attenuation lung areas on paired expiratory CT scans (%LAA-856 or expiratory/inspiratory ratio) across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Percentage Wall Thickness (WT%) Across GOLD Stages
Time frame: Baseline
Volumetric CT quantitative measurement of bronchial wall thickness expressed as a percentage of total bronchial outer diameter evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Absolute Wall Area (WA) Across GOLD Stages
Time frame: Baseline
Volumetric CT quantitative measurement of absolute bronchial wall cross-sectional area evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Millimeter (mm)
2 secondary outcomes
Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio
Time frame: Baseline (same day or within 1 week of HRCT scan)
Correlation Coefficient Between CT Air Trapping Percentage (AT%) and Plethysmographic RV/TLC Ratio
Time frame: Baseline (same day or within 1 week of HRCT scan)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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. This study is not recruiting at the moment.
Nesreen Shalabi principal investigator
Professor of Chest Diseases
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 Chronic Obstructive Pulmonary Disease and Pulmonary Emphysema, run by Mansoura 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 0 inclusion and 24 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: finished, as of the sponsor's last update on 9 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emphysema Percentage (EM%) Across GOLD Stages (time frame: Baseline). The study lists 6 primary outcomes in all. 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 9 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.