Quantitative Study on HRCT Phenotype of COPD

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04953611
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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 Timeline

• Study Start: 2013-07-01
• Primary Completion: 2014-11-30
• Study Completion: 2014-11-30
• Status Verified: 2021-06
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China