Clinical trial NCT03044847: The Cohort Study for Chronic Obstructive Pulmonary Disease (COPD) in China
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 type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 3800
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tier 2 or tier 3 hospitals in China

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.

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.

Eligibility 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

Primary outcomes:
measure: COPD-related mortality and all-cause mortality
timeFrame: 10 years
Secondary outcomes:
measure: COPD exacerbation rate per year
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Kewu Huang, M.D.
role: STUDY_DIRECTOR
References: