Quantitative Study on HRCT Phenotype of COPD

NCT04953611 | Completed DMC

• 1 other identifier: 2013116
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary disease; chronic obstructive; Phenotype

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (5)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive outpatients

You may qualify if:

• Age between 40 and 80 (including 40 and 80)
• It meets the diagnostic criteria for COPD
• 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;
• Voluntarily agree to participate in this study

You may not qualify if:

• Older than 80 or younger than 40
• Pregnant women
• 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
• Previous lung surgery
• Cognitive dysfunction
• Unable to cooperate with lung function test.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100080, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 8, 2021
• Study Start: July 1, 2013
• Primary Completion: November 30, 2014
• Study Completion: November 30, 2014
• Last Updated: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)