Effects of Particulate Matter on the Pulmonary Function and Acute Exacerbation of COPD and Asthma

Effects of Particulate Matter on the Lung Function and Acute Exacerbation of COPD and Asthma Patients--A Multi-center Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03193879

Enrollment

505

Registered

2017-06-21

Start date

2015-12-31

Completion date

2021-09-30

Last updated

2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Function

Keywords

Pulmonary function, Particulate matter, COPD, Asthma

Brief summary

Detailed description

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. This study is an observational study which lasts 3 years. Primary outcome measures:Change in spirometry (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure doses of PM.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

1. COPD patients: clinical manifestation of COPD; post bronchodilator FEV1/FVC\<0.70. 2. 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. 3. Asthma combined with COPD (ACOS) patients: patients with ACOS are included in asthma group. 4. Healthy volunteers: No smoking history, or have quit smoking at least 5 years. Chest X-ray show no abnormality. 5. Information consent form should be signed before entering the study.

Exclusion criteria

1. The latest severe acute attack occurred within 4 weeks: 1. Severe acute attack: status asthmaticus or acute exacerbation of COPD leading to consultation, emergency treatment，hospitalization, or glucocorticoid treatment（oral/i.v). 2. 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. 2. Any history of acute/chronic respiratory diseases other than asthma and COPD, including lung cancer and pulmonary infection. 3. 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. 4. Left heart insufficiency, or malignant arrhythmia. 5. HIV positive. 6. Acute cerebrovascular events within 3 months, including apoplexy, transient cerebral ischemia and acute coronary syndrome. 7. Uncured malignant tumors. 8. Addicted to drug or alcohol, or any history of psychiatric disorders. 9. Breastfeeding, pregnancy or planning to be pregnant. 10. Estimated lifetime less than 2 years due to underlying diseases.

Design outcomes

Primary

Measure	Time frame	Description
Change in spirometry (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure doses of PM.	2 years	Spirometry will be assessed at baseline and through study completion, an average of 2 years.

Secondary

Measure	Time frame	Description
Change in morbidity of acute exacerbation in COPD and asthma patients in response to different exposure doses of PM.	2 years	Patients will be followed up through study completion, an average of 2 years.

Countries

China

Outcome results