NCT03044847

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 3,800 (estimated)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2017-02-07
• Last updated: 2021-07-29

Locations

1 site across 1 country: China