Volumetric HRCT in Stable COPD Patients.

NCT07809399 | Completed

• 1 other identifier: MS.25.02.3101
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Emphysema; Airway Obstruction

Keywords

Volumetric HRCT; Pulmonary Function Test

Outcome Measures

Primary Outcomes (6)

• 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 (%)

  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).

  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 (%)

  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 (%)

  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 (%)

  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)

  Baseline

Secondary Outcomes (2)

• Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio

  Baseline (same day or within 1 week of HRCT scan)

• Correlation Coefficient Between CT Air Trapping Percentage (AT%) and Plethysmographic RV/TLC Ratio

  Baseline (same day or within 1 week of HRCT scan)

Other Outcomes (1)

• Correlation Coefficient Between CT Emphysema Percentage (EM%) and Arterial Oxygen Tension (pO2)

  Baseline

Study Arms (1)

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

Diagnostic Test: Volumetric HRCT chest; Diagnostic Test: Spirometry and Body Plethysmography

Interventions

Volumetric HRCT chest DIAGNOSTIC_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%

Stable COPD Patients

Spirometry and Body Plethysmography DIAGNOSTIC_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).

Stable COPD Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosed according to GOLD criteria (post-bronchodilator FEV1/FVC \< 0.70)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital (Chest Disease Department)

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Airway Obstruction

Interventions

Spirometry; Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Plethysmography; Diagnostic Techniques, Cardiovascular

Study Officials

• Nesreen Shalabi

  Professor of Chest Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 9, 2026
• Study Start: April 20, 2025
• Primary Completion: May 20, 2026
• Study Completion: August 20, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-08

Locations

EG (1)