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Completed

NCT Number: NCT04953611

Quantitative Study on HRCT Phenotype of COPD

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

Completed

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, 100080, China

About this study

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:

  • 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.
  • The GOLD Combined assessment staging system helps doctors choose an individualized treatment for the COPD patients

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. The severity of emphysema

    Time frame: Within an average of 3 days after diagnosis of COPD

    % low attenuation area <950 HU (LAA %)

  2. Indicator A of the severity of airway stenosis

    Time frame: Within an average of 3 days after diagnosis of COPD

    The inner diameter of bronchial (LD) in centimeter

  3. Indicator B of the severity of airway stenosis

    Time frame: Within an average of 3 days after diagnosis of COPD

    The bronchial wall thickness in centimeter

  4. Indicator C of the severity of airway stenosis

    Time frame: Within an average of 3 days after diagnosis of COPD

    Ratio of thickness and outer diameter (TDR)

  5. Indicator D of the severity of airway stenosis

    Time frame: Within an average of 3 days after diagnosis of COPD

    % wall area for bronchial external diameter (WA%)

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Quantitative Study on HRCT Phenotype of the GOLD COPD Assessment Staging

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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