The Cohort Study for Chronic Obstructive Pulmonary Disease (COPD) in China

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

The Cohort Study for Chronic Obstructive Pulmonary Diseases (COPD) in China---- Observation of the Disease Outcome and Identification of Prognostic Biomarkers for the Disease Outcome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03044847
• Other study ID #: 2016YFC0901102
• Secondary ID: ESR-16-12485
• Status: Enrolling by invitation
• Start date: July 2016
• Est. completion date: December 2028

Study information

• Verified date: July 2021
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to establish the large COPD cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices and to monitor and improve clinical outcomes in this disease.

Description:

This is a 5-year multi-center observational prospective longitudinal cohort study to to establish the large COPD cohort and biological database in China, including COPD subjects( n= 3000) and GOLD 0 subjects (n= 800).Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct pulmonary function test, HRCT.Patients must meet all the inclusion criteria and none of the exclusion criteria.No additional investigational drugs will be applied to the patients. Full analysis set will be used for all analyses. Missing data will be analysed as it is. Statistical analysis will be conducted by epidemiology & statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used.Questionnaire variables will be checked before data entry.During the study, PI will be in charge of the monitoring of the whole procedure. Two working group will do the data cleaning and data analysing.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3800
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 40-75 years

• COPD group: baseline post-bronchodilator FEV1/FVC < 0.7

• GOLD 0 group: individuals with chronic respiratory symptoms and/or high risk factors

• Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years

Exclusion Criteria:

• Acute exacerbation in the past 3 months

• Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc

• The usual criteria of serious uncontrolled diseases

• thoracic or abdominal surgery in the last 3 months

• eye surgery in the last three months

• retinal detachment

• myocardial infarction in the last 3 months

• admission to hospital for any cardiac condition in the last month

• heart rate over 120 beats per minute

• antibacterial chemotherapy for tuberculosis

• pregnant or breast feeding

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• COPD group
The treatments will be determined by their treating physicians and no additional investigational drugs will be applied to the patients included in this study.

Locations

Country	Name	City	State
China	Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD-related mortality and all-cause mortality	COPD-related mortality and all-cause mortality	10 years
Secondary	COPD exacerbation rate per year	COPD exacerbation rate per year	10 years