- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05076630
Air Pollution and Health of COPD Patients
May 28, 2025 updated by: Furong Deng, Peking University
Effect of Air Pollution on Prognosis of Patients With Chronic Obstructive Pulmonary Disease and Its Underlying Biological Mechanism
This panel study aims to evaluate the effects of air pollutants on cardiopulmonary health of patients with chronic obstructive pulmonary disease (COPD) and explore the potential biological mechanisms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This panel study was conducted in a group of stable patients with COPD in Beijing, China.
The health measurements including lung function, blood pressure and airway inflammation were conducted, and morning urine, exhaled breath condensate, saliva and venous blood were collected at the time of enrollment and at 3, 6 and 9 months after enrollment.
Individual exposures to fine particulate matter (PM2.5),
black carbon (BC), ozone (O3) and nitrogen dioxide (NO2) were performed for 24 hours at each follow-up.
And the daily concentrations of air pollutants were collected from the Beijing Air Quality Real-time Publishing Platform and meteorological data were collected from the National Meteorological Information Center.
The linear mixed effects model was used to analyze the association between air pollution and cardiopulmonary health in patients with COPD.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100191
- Peking University
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Stable COPD patients aged 40-80 in Beijing, China
Description
Inclusion Criteria:
- doctor-diagnosed stable COPD patients
- aged 40 to 80 years
- lived in Beijing for over one year before being recruited
- Agree to participate and sign the informed consent form.
Exclusion Criteria:
- Patients with a history of acute exacerbation in the last 1 month
- Patients with other respiratory diseases such as bronchiectasis and asthma.
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: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung function
Time Frame: Nine months
|
Lung function test was conducted.
|
Nine months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COPD Assessment Test scores
Time Frame: Nine months
|
COPD Assessment Test (CAT) scores were used to assess quality of life in COPD patients on a scale of 0 to 40, with higher scores associated with poorer outcomes.
|
Nine months
|
|
Modified British Medical Research Council (mMRC) Questionnaire score
Time Frame: Nine months
|
Modified British Medical Research Council (mMRC) Questionnaire score was used to assess the severity of dyspnea on a scale of 0 to 4, with a higher score indicating a worse outcome.
|
Nine months
|
|
ST. George's Respiratory Questionnaire scores
Time Frame: Nine months
|
ST. George's Respiratory Questionnaire (SGRQ) scores were used to assess quality of life in patients with COPD on a scale of 0 to 100, with higher scores indicating poorer outcomes.
|
Nine months
|
|
Blood pressure
Time Frame: Nine months
|
Systolic and diastolic blood pressure of participants were measured at least three times by a trained technician.
|
Nine months
|
|
Respiratory inflammation
Time Frame: Nine months
|
Fractional exhaled nitric oxide (FeNO) test was conducted.
|
Nine months
|
|
Airway and systemic oxidative stress levels
Time Frame: Nine months
|
Exhaled Breath Condensate (EBC) and urine samples were collected for oxidative stress analysis.
|
Nine months
|
|
Systemic inflammation
Time Frame: Nine months
|
Venous blood was collected for determination of systemic inflammatory biomarkers.
|
Nine months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Furong Deng, Doctor, Peking University
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)
October 12, 2021
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
September 16, 2021
First Submitted That Met QC Criteria
October 1, 2021
First Posted (Actual)
October 13, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2025
Last Update Submitted That Met QC Criteria
May 28, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00001052-21085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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