Clinical Phenotypes of COPD Patients Between in Plateau and Plain

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: No intervention

• Registration Number: NCT04964076
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-15
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients in the plateau	No intervention	We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Tibet Autonomous Region People's Hospital from January 2018 to December 2021.
COPD patients in the plain	No intervention	We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Peking University Third Hospital from January 2018 to December 2021.

Primary Outcome Measures

Name	Time	Method
Assessment of respiratory symptoms	Data were obtained during the interview.	COPD Assessment Test
Exacerbation	Data were obtained during the interview.	Frequency of exacerbations in the past year
Emphysema	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.
Airway remodeling -2	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.
Spirometry testing	Data were obtained during the interview.	FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC
Airway remodeling -3	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.
Airway remodeling -1	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China