Air Pollution and Health of COPD Patients

Sponsor
Peking University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076630
Collaborator
(none)
100
1
14.6
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Air pollutants

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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Effect of Air Pollution on Prognosis of Patients With Chronic Obstructive Pulmonary Disease and Its Underlying Biological Mechanism
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Lung function [Nine months]

    Lung function test was conducted.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. Blood pressure [Nine months]

    Systolic and diastolic blood pressure of participants were measured at least three times by a trained technician.

  5. Respiratory inflammation [Nine months]

    Fractional exhaled nitric oxide (FeNO) test was conducted.

  6. Airway and systemic oxidative stress levels [Nine months]

    Exhaled Breath Condensate (EBC) and urine samples were collected for oxidative stress analysis.

  7. Systemic inflammation [Nine months]

    Venous blood was collected for determination of systemic inflammatory biomarkers.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Beijing China 100191

Sponsors and Collaborators

  • Peking University

Investigators

  • Principal Investigator: Furong Deng, Doctor, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Furong Deng, Deputy Director of Department of Occupational and Environmental Health Sciences, Peking University
ClinicalTrials.gov Identifier:
NCT05076630
Other Study ID Numbers:
  • IRB00001052-21085
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Furong Deng, Deputy Director of Department of Occupational and Environmental Health Sciences, Peking University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021