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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: COPD group

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 3800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Tier 2 or tier 3 hospitals in China

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD group; The post-bronchodilator FEV1/FVC ratio < 0.70 was used as definition of COPD, which was proposed by the Global Initiative for Chronic Obstructive Lung Disease	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.
GOLD 0 group; GOLD 0 is defined as having chronic respiratory symptoms and/or high risk factors, but without airflow (post-BD FEV1/FVC ≥ 0.7). Chronic respiratory symptoms is defined as chronic cough, phlegm production, chest tightness, short of breath, dyspnea, wheeze, ect. High risk factors is defined as cigarette smoking, passive smoking, occupational exposures, bio-fuels exposures ect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD-related mortality and all-cause mortality	COPD-related mortality and all-cause mortality	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD exacerbation rate per year	COPD exacerbation rate per year	10 years

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2028
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2016YFC0901102; ESR-16-12485 (Other Identifier: China-Japan Friendship Hospital, Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: no plan to share IPD