Quantitative Study on HRCT Phenotype of COPD

Quantitative Study on HRCT Phenotype of the GOLD COPD Assessment Staging

To explore the HRCT phenotype of the combined COPD assessment staging system

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

HRCT can be rapidly and safely deployed has enabled COPD research to move beyond FEV1 by facilitating and amplifying clinical phenotyping measurements, providing quantitative information, and detecting significant responses to therapy even in the absence of significant FEV1 improvements.

We explore the HRCT phenotype of the combined COPD assessment staging system,and found that:

1. Airway remodeling occurs in COPD patients. CT shows varying degrees of bronchial wall thickness, area increasing and emphysema as the new GOLD classification Group A-D arising.
2. The GOLD Combined assessment staging system helps doctors choose an individualized treatment for the COPD patients

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100080
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive outpatients

Description

Inclusion Criteria:

1. Age between 40 and 80 (including 40 and 80)
2. It meets the diagnostic criteria for COPD
3. No language communication barriers, or the family members who know the condition can complete the questionnaire on behalf of the patient, and the data are reliable;
4. Voluntarily agree to participate in this study

Exclusion Criteria:

1. Older than 80 or younger than 40
2. Pregnant women
3. Complicating with other lung diseases, such as asthma, pneumonia, bronchiectasis, lung abscess, interstitial lung disease, confirmed and suspected lung cancer of lung shadow, active pulmonary tuberculosis, etc
4. Previous lung surgery
5. Cognitive dysfunction
6. Unable to cooperate with lung function test.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Group A in GOLD; CAT<10、mMRC 0-1、FEV1%≥50%、the frequency of acute exacerbations in the past year<2；
Group B in GOLD; CAT≥10、mMRC≥2、FEV1%≥50%、the frequency of acute exacerbations in the past year<2
Group C in GOLD; CAT<10、mMRC 0-1、 FEV1%<50%、the frequency of acute exacerbations in the past year≥2 or leading to hospital admission≥1
Group D in GOLD; CAT≥10、mMRC≥2、FEV1%<50%、the frequency of acute exacerbations in the past year≥2 or leading to hospital admission≥1
Control Group; not COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of emphysema	% low attenuation area <950 HU (LAA %)	Within an average of 3 days after diagnosis of COPD
Indicator A of the severity of airway stenosis	The inner diameter of bronchial (LD) in centimeter	Within an average of 3 days after diagnosis of COPD
Indicator B of the severity of airway stenosis	The bronchial wall thickness in centimeter	Within an average of 3 days after diagnosis of COPD
Indicator C of the severity of airway stenosis	Ratio of thickness and outer diameter (TDR)	Within an average of 3 days after diagnosis of COPD
Indicator D of the severity of airway stenosis	% wall area for bronchial external diameter (WA%)	Within an average of 3 days after diagnosis of COPD

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): November 30, 2014
• Study Completion (Actual): November 30, 2014

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pulmonary disease; chronic obstructive; Phenotype
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2013116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No