Clinical Phenotypes of COPD Patients Between in Plateau and Plain

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964076
• Other study ID #: LM2020390
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Tibet Autonomous Region People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of respiratory symptoms	COPD Assessment Test	Data were obtained during the interview.
Primary	Exacerbation	Frequency of exacerbations in the past year	Data were obtained during the interview.
Primary	Spirometry testing	FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC	Data were obtained during the interview.
Primary	Emphysema	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.	Within 3 months of the interview.
Primary	Airway remodeling -1	Bronchial wall thickness (WT, mm) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.	Within 3 months of the interview.
Primary	Airway remodeling -2	Luminal area (LA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.	Within 3 months of the interview.
Primary	Airway remodeling -3	Bronchial wall area (WA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.	Within 3 months of the interview.