- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04964076
Clinical Phenotypes of COPD Patients Between in Plateau and Plain
November 16, 2023 updated by: Sun Yongchang, Peking University Third Hospital
Clinical and Radiological Phenotypes of Patients With Stable COPD Between in Plateau and Plain
We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (COPD) in plateau and plain.
We conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.
Study Type
Observational
Enrollment (Actual)
104
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: Yongchang Sun, M.D.
- Phone Number: 86-15611963697
- Email: suny@bjmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking University Third Hospital
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
We consecutively enrolled patients with COPD from January 2018 to December 2021, who visited the outpatient of Department of Respiratory Medicine in Peking University Third Hospital or Tibet Autonomous Region People's Hospital.
Description
Inclusion Criteria:
- meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)<0.7.
Exclusion Criteria:
- age <40 years;
- subjects with airway diseases other than COPD;
- acute exacerbation of COPD in the past 3 months;
- active tuberculosis;
- cardiovascular or cerebrovascular events in the past 3 months;
- cognitive dysfunction such as vascular dementia or Alzheimer's disease;
- refusal to participate in this study.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COPD patients in the plateau
We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Tibet Autonomous Region People's Hospital from January 2018 to December 2021.
|
No intervention
|
COPD patients in the plain
We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Peking University Third Hospital from January 2018 to December 2021.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of respiratory symptoms
Time Frame: Data were obtained during the interview.
|
COPD Assessment Test
|
Data were obtained during the interview.
|
Exacerbation
Time Frame: Data were obtained during the interview.
|
Frequency of exacerbations in the past year
|
Data were obtained during the interview.
|
Spirometry testing
Time Frame: Data were obtained during the interview.
|
FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC
|
Data were obtained during the interview.
|
Emphysema
Time Frame: Within 3 months of the interview.
|
The percentage of the LAA divided by total lung volumes (LAA%) was used as an index of the severity of emphysema in quantitative CT examination.
|
Within 3 months of the interview.
|
Airway remodeling -1
Time Frame: Within 3 months of the interview.
|
Bronchial wall thickness (WT, mm) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
|
Within 3 months of the interview.
|
Airway remodeling -2
Time Frame: Within 3 months of the interview.
|
Luminal area (LA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
|
Within 3 months of the interview.
|
Airway remodeling -3
Time Frame: Within 3 months of the interview.
|
Bronchial wall area (WA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
|
Within 3 months of the interview.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yongchang Sun, M.D., Peking University Third Hospital
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)
November 1, 2020
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 15, 2021
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LM2020390
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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