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

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Capital Medical University

Status

Invitation-only

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Other: COPD group

Study type

Observational

Funder types

Other

Identifiers

NCT03044847
2016YFC0901102
ESR-16-12485 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,800 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

3,800 participants in 2 patient groups

COPD group
Description:
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
Treatment:
Other: COPD group
GOLD 0 group
Description:
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.

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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