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Completed

NCT Number: NCT04964076

Clinical Phenotypes of COPD Patients Between in Plateau and Plain

We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

The purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (COPD) in plateau and plain. We conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)<0.7.

Exclusion criteria

  • age <40 years;
  • subjects with airway diseases other than COPD;
  • acute exacerbation of COPD in the past 3 months;
  • active tuberculosis;
  • cardiovascular or cerebrovascular events in the past 3 months;
  • cognitive dysfunction such as vascular dementia or Alzheimer's disease;
  • refusal to participate in this study.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Assessment of respiratory symptoms

    Time frame: Data were obtained during the interview.

    COPD Assessment Test

  2. Exacerbation

    Time frame: Data were obtained during the interview.

    Frequency of exacerbations in the past year

  3. Spirometry testing

    Time frame: Data were obtained during the interview.

    FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC

  4. Emphysema

    Time frame: Within 3 months of the interview.

    The percentage of the LAA divided by total lung volumes (LAA%) was used as an index of the severity of emphysema in quantitative CT examination.

  5. Airway remodeling -1

    Time frame: Within 3 months of the interview.

    Bronchial wall thickness (WT, mm) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.

  6. Airway remodeling -2

    Time frame: Within 3 months of the interview.

    Luminal area (LA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.

  7. Airway remodeling -3

    Time frame: Within 3 months of the interview.

    Bronchial wall area (WA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Tibet Autonomous Region People's Hospital

Registry information

Official study title

Clinical and Radiological Phenotypes of Patients With Stable COPD Between in Plateau and Plain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2021
Registry last updated
Nov 18, 2023

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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