GIRH Chronic Obstructive Pulmonary Disease Observational Study

March 26, 2019 updated by: zili zhang

A Observational Study in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

-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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pulmonary function
biological sample detection outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of FEV1 at 12 months from baseline
Time Frame: at 12 months
difference of FEV1 at 12 months from baseline
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2018

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Respiratory disease of GIRH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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