NCT03193879

Brief Summary

Particulate matter(PM) exposure has been shown to increase the morbidity and mobility of a variety of respiratory diseases, including COPD and asthma. This study focus on the effects of PM on the pulmonary function and acute exacerbation of COPD and asthma patients in China, where PM exposure is much heavier than the United States and European countries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5.8 years

First QC Date

June 14, 2017

Last Update Submit

September 18, 2021

Conditions

Pulmonary Function

Keywords

Pulmonary functionParticulate matterCOPDAsthma

Outcome Measures

Primary Outcomes (1)

  • Change in spirometry (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure doses of PM.

    Spirometry will be assessed at baseline and through study completion, an average of 2 years.

    2 years

Secondary Outcomes (1)

  • Change in morbidity of acute exacerbation in COPD and asthma patients in response to different exposure doses of PM.

    2 years

Study Arms (3)

COPD group

COPD patients

Asthma group

Asthma patients

Health group

Healthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinic-based population

You may qualify if:

  • COPD patients: clinical manifestation of COPD; post bronchodilator FEV1/FVC\<0.70.
  • Asthma patients: clinical manifestation of asthma; recurrent dyspnea; with or without wheezing; relief spontaneously or after using bronchodilators; FEV1/FVC\<0.70,with positive bronchial reversible test.
  • Asthma combined with COPD (ACOS) patients: patients with ACOS are included in asthma group.
  • Healthy volunteers: No smoking history, or have quit smoking at least 5 years. Chest X-ray show no abnormality.
  • Information consent form should be signed before entering the study.

You may not qualify if:

  • The latest severe acute attack occurred within 4 weeks:
  • Severe acute attack: status asthmaticus or acute exacerbation of COPD leading to consultation, emergency treatment，hospitalization, or glucocorticoid treatment（oral/i.v).
  • Controllable non-hospitalized acute attack without glucocorticoid treatment(oral/i.v). COPD attack lasting less than 48h or asthma attack lasting less than 24h are not excluded.
  • Any history of acute/chronic respiratory diseases other than asthma and COPD, including lung cancer and pulmonary infection.
  • Plasma ALT or AST greater than 2 times of the upper normal limit; plasma Creatinine greater than 1.5 times of the upper normal limit.
  • Left heart insufficiency, or malignant arrhythmia.
  • HIV positive.
  • Acute cerebrovascular events within 3 months, including apoplexy, transient cerebral ischemia and acute coronary syndrome.
  • Uncured malignant tumors.
  • Addicted to drug or alcohol, or any history of psychiatric disorders.
  • Breastfeeding, pregnancy or planning to be pregnant.
  • Estimated lifetime less than 2 years due to underlying diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens are preserved in serum, plasma, and leukocytes

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 21, 2017

Study Start

December 1, 2015

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

CN(1)