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

• ClinicalTrials.gov Identifier: NCT03044847
• Recruitment Status: Enrolling by invitation
• First Posted: February 7, 2017
• Last Update Posted: July 29, 2021
• Sponsor: Beijing Chao Yang Hospital
• Information provided by (Responsible Party): Kewu Huang, Beijing Chao Yang Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Pulmonary Disease, Chronic Obstructive	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 Design

• Study Type: Observational
• Estimated Enrollment: 3800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: July 2016
• Estimated Primary Completion Date: December 2028
• Estimated Study Completion Date: December 2028

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. COPD-related mortality and all-cause mortality [ Time Frame: 10 years ]
   COPD-related mortality and all-cause mortality

Secondary Outcome Measures :

1. COPD exacerbation rate per year [ Time Frame: 10 years ]
   COPD exacerbation rate per year

Biospecimen Description:

whole blood and sputum

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Tier 2 or tier 3 hospitals in China

Criteria

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

Contacts and Locations

Locations

China, Beijing

Capital Medical University

Beijing, Beijing, China

Sponsors and Collaborators

Beijing Chao Yang Hospital

Investigators

• Study Director: Kewu Huang, M.D.; Beijing Chao Yang Hospital

  Study Documents (Full-Text)

Documents provided by Kewu Huang, Beijing Chao Yang Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] November 16, 2016

Informed Consent Form  [PDF] May 24, 2017

More Information

• Responsible Party: Kewu Huang, Professor/M.D., Beijing Chao Yang Hospital
• ClinicalTrials.gov Identifier: NCT03044847
• Other Study ID Numbers: 2016YFC0901102; ESR-16-12485 ( Other Identifier: China-Japan Friendship Hospital, Ministry of Health )
• First Posted: February 7, 2017
• Last Update Posted: July 29, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: no plan to share IPD

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes