Quantitative Study on HRCT Phenotype of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Quantitative Study on HRCT Phenotype of the GOLD COPD Assessment Staging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953611
• Other study ID #: 2013116
• Status: Completed
• Start date: July 1, 2013
• Est. completion date: November 30, 2014

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2014
• Est. primary completion date: November 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of emphysema	% low attenuation area <950 HU (LAA %)	Within an average of 3 days after diagnosis of COPD
Primary	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
Primary	Indicator B of the severity of airway stenosis	The bronchial wall thickness in centimeter	Within an average of 3 days after diagnosis of COPD
Primary	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
Primary	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