Air Pollution and Health of COPD Patients

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05076630
• Lead Sponsor: Peking University

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-10-01
• Study Start: 2021-10-12
• Study First Posted: 2021-10-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung function	Nine months	Lung function test was conducted.

Secondary Outcome Measures

Name	Time	Method
Modified British Medical Research Council (mMRC) Questionnaire score	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.
ST. George's Respiratory Questionnaire scores	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.
Blood pressure	Nine months	Systolic and diastolic blood pressure of participants were measured at least three times by a trained technician.
Respiratory inflammation	Nine months	Fractional exhaled nitric oxide (FeNO) test was conducted.
Systemic inflammation	Nine months	Venous blood was collected for determination of systemic inflammatory biomarkers.
COPD Assessment Test scores	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.
Airway and systemic oxidative stress levels	Nine months	Exhaled Breath Condensate (EBC) and urine samples were collected for oxidative stress analysis.

Trial Locations

Locations (1)

Peking University; 🇨🇳 Beijing, China