Air Pollution and Health of COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Air Pollution on Prognosis of Patients With Chronic Obstructive Pulmonary Disease and Its Underlying Biological Mechanism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05076630
• Other study ID #: IRB00001052-21085
• Status: Active, not recruiting
• Start date: October 12, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Air pollutants
Particulate matter and gaseous pollutants

Locations

Country	Name	City	State
China	Peking University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function	Lung function test was conducted.	Nine months
Secondary	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.	Nine months
Secondary	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.	Nine months
Secondary	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.	Nine months
Secondary	Blood pressure	Systolic and diastolic blood pressure of participants were measured at least three times by a trained technician.	Nine months
Secondary	Respiratory inflammation	Fractional exhaled nitric oxide (FeNO) test was conducted.	Nine months
Secondary	Airway and systemic oxidative stress levels	Exhaled Breath Condensate (EBC) and urine samples were collected for oxidative stress analysis.	Nine months
Secondary	Systemic inflammation	Venous blood was collected for determination of systemic inflammatory biomarkers.	Nine months