- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893409
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
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
- Name: zhang zili, PHD
- Phone Number: 18922269968
- Email: zhangzili_04@163.com
Study Contact Backup
- Name: Dan zhang, foundation
- Phone Number: 18933917741
- Email: 853250935@qq.com
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 |
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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
Additional Relevant MeSH Terms
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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