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

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

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 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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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.



Primary Outcome Measures :
  1. COPD-related mortality and all-cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. COPD exacerbation rate per year [ Time Frame: 5 years ]
  2. 6-minute walk test decline in 5 years [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044847


Contacts
Contact: Yan Li, Ph.D. 86010-83950199 liyanok@126.com
Contact: Ying Wang, M.D. 8613426121753 kokosalaki1020@sina.com

Locations
China, Beijing
Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Yan Li, Ph.D.    86010-83950199    liyanok@126.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
Study Director: Kewu Huang, M.D. Beijing Chao Yang Hospital

Responsible Party: Kewu Huang, Professor/M.D., Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT03044847     History of Changes
Other Study ID Numbers: 2016YFC0901102
ESR-16-12485 ( Other Identifier: China-Japan Friendship Hospital, Ministry of Health )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes