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

NCT03044847 | Enrolling By Invitation DMC

• 2 other identifiers: 2016YFC0901102ESR-16-12485
• Study Type: observational
• Target: 3,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• COPD-related mortality and all-cause mortality

  COPD-related mortality and all-cause mortality

  10 years

Secondary Outcomes (1)

• COPD exacerbation rate per year

  10 years

Study Arms (2)

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

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.

Interventions

COPD group OTHER

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

COPD group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tier 2 or tier 3 hospitals in China

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Capital Medical University

Beijing, Beijing Municipality, China

Location

Biospecimen

whole blood and sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kewu Huang, M.D.

  Beijing Chao Yang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/M.D.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 7, 2017
• Study Start: July 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)