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

NCT ID: NCT03193879

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD group

COPD patients

No interventions assigned to this group

Asthma group

Asthma patients

No interventions assigned to this group

Health group

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xinjiang Autonomous Region People 's Hospital

UNKNOWN

Sponsor Role collaborator

Cangzhou Central Hospital

OTHER

Sponsor Role collaborator

Chengdu sixth People 's Hospital

UNKNOWN

Sponsor Role collaborator

Chengde Central Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Fengtai Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Medical College, Ningbo University

OTHER

Sponsor Role collaborator

Changzhi Medical College

OTHER

Sponsor Role collaborator

Beijing Boai Hospital

OTHER

Sponsor Role collaborator

Wuhu County Traditional Chinese Medicine Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Jingzhou

OTHER

Sponsor Role collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role collaborator

Harbin Zhongshan Asthma Hospital

UNKNOWN

Sponsor Role collaborator

Rizhao Hospital of Chinese Traditional Medicine

UNKNOWN

Sponsor Role collaborator

3201 Hospital in Hanzhong

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Chengdu Fifth People's Hospital

OTHER

Sponsor Role collaborator

First People 's Hospital of Changsha

UNKNOWN

Sponsor Role collaborator

Chongqing Jiangjin Central Hospital

UNKNOWN

Sponsor Role collaborator

the Affiliated hospital of Guilin medical university, China

UNKNOWN

Sponsor Role collaborator

Jiangxi People 's Hospital

UNKNOWN

Sponsor Role collaborator

Chinese People 's Liberation Army Navy Anqing Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

Yancheng Dafeng People 's Hospital

UNKNOWN

Sponsor Role collaborator

ShuGuang Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of the Fourth Military Medical University

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Third Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

First People 's Hospital of Kunming

UNKNOWN

Sponsor Role collaborator

First People 's Hospital of Yunnan

UNKNOWN

Sponsor Role collaborator

Pingxiang People 's Hospital

UNKNOWN

Sponsor Role collaborator

Northern Jiangsu People 's Hospital

UNKNOWN

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

The Second Economic Hospital of Xinjiang Uygur Autonomous Region

UNKNOWN

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2015CB553402

Identifier Type: -

Identifier Source: org_study_id

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