Chronic Obstructive Pulmonary DiseaseNCT05076630
Air Pollution and Health of COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Air pollutants
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable COPD patients aged 40-80 in Beijing, China
Who may be able to join
- 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.
Who cannot join
- Patients with a history of acute exacerbation in the last 1 month
- Patients with other respiratory diseases such as bronchiectasis and asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Air pollutants
- Keywords
- Air pollution, chronic obstructive pulmonary disease, cardiopulmonary health, biological mechanism
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air pollutantsOther
Particulate matter and gaseous pollutants
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Lung function test was conducted.
Measured: Nine months
Secondary outcomes (7)
COPD Assessment Test scores
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.
Measured: Nine months
Modified British Medical Research Council (mMRC) Questionnaire score
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.
Measured: Nine months
ST. George's Respiratory Questionnaire scores
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.
Measured: Nine months
Blood pressure
Systolic and diastolic blood pressure of participants were measured at least three times by a trained technician.
Measured: Nine months
Respiratory inflammation
Fractional exhaled nitric oxide (FeNO) test was conducted.
Measured: Nine months
Airway and systemic oxidative stress levels
Exhaled Breath Condensate (EBC) and urine samples were collected for oxidative stress analysis.
Measured: Nine months
Systemic inflammation
Venous blood was collected for determination of systemic inflammatory biomarkers.
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start12 Oct 2021
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furong Deng, Peking University
- Investigators
- Furong Deng, Doctor, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076630
- Sponsor's protocol ID
- IRB00001052-21085
- Status last verified
- May 2025
- First submitted
- 16 Sep 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang W, Chen B, Shima M, Zhao C, Guo L, Yoda Y, Li S, Wu S, Chen Y, Guo X, Deng F. PM2.5 as a risk factor for sleep oxygen desaturation in COPD: identifying susceptible individuals by smoking and inflammatory phenotypes. Thorax. 2025 Sep 15;80(10):683-692. doi: 10.1136/thorax-2025-223140.
PubMed 40541407
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Air Pollution on Prognosis of Patients With Chronic Obstructive Pulmonary Disease and Its Underlying Biological Mechanism
- ClinicalTrials.gov ID
- NCT05076630
- Acronym / sponsor ID
- IRB00001052-21085
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Air pollution, chronic obstructive pulmonary disease, cardiopulmonary health, biological mechanism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable COPD patients aged 40-80 in Beijing, China
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a history of acute exacerbation in the last 1 month
- Patients with other respiratory diseases such as bronchiectasis and asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air pollutantsParticulate matter and gaseous pollutants | Other | – |
Primary outcome
Lung function
Time frame: Nine months
Lung function test was conducted.
7 secondary outcomes
COPD Assessment Test scores
Time frame: Nine months
Modified British Medical Research Council (mMRC) Questionnaire score
Time frame: Nine months
ST. George's Respiratory Questionnaire scores
Time frame: Nine months
Blood pressure
Time frame: Nine months
Respiratory inflammation
Time frame: Nine months
Airway and systemic oxidative stress levels
Time frame: Nine months
Systemic inflammation
Time frame: Nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 40541407Zhang W, Chen B, Shima M, Zhao C, Guo L, Yoda Y, Li S, Wu S, Chen Y, Guo X, Deng F. PM2.5 as a risk factor for sleep oxygen desaturation in COPD: identifying susceptible individuals by smoking and inflammatory phenotypes. Thorax. 2025 Sep 15;80(10):683-692. doi: 10.1136/thorax-2025-223140.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furong Deng, Doctor principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: Nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.