GIRH Chronic Obstructive Pulmonary Disease Observational Study

NCT03893409 | Unknown

• 1 other identifier: Respiratory disease of GIRH
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• difference of FEV1 at 12 months from baseline

  difference of FEV1 at 12 months from baseline

  at 12 months

Study Arms (2)

pulmonary function

biological sample detection outcome

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a observational prospective longitudinal cohort study to to establish the large COPD cohort and biological database in China, including COPD subjects( n= 5000) and healthy subjects (n= 5000). 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. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and R software. 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.

You may qualify if:

• Aged 40-70 years COPD group: baseline post-bronchodilator FEV1/FVC \< 0.7 Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years

You may not qualify if:

• 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

Sponsors & Collaborators

• zili zhang: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

zhang zili, PHD

CONTACT

18922269968; zhangzili_04@163.com

Dan zhang, foundation

CONTACT

18933917741; 853250935@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guangzhou Medical University

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: August 10, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2022
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)