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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03193879

Collaborator

Xinjiang Autonomous Region People 's Hospital (Other), Cangzhou Central Hospital (Other), Chengdu sixth People 's Hospital (Other), Chengde Central Hospital (Other), Beijing Fengtai Hospital (Other), The Affiliated Hospital of Medical College, Ningbo University (Other), Changzhi Medical College (Other), Beijing Boai Hospital (Other), Wuhu Hospital of Chinese Traditional Medicine (Other), The First People's Hospital of Jingzhou (Other), Fujian Provincial Hospital (Other), Harbin Zhongshan Asthma Hospital (Other), Rizhao Hospital of Chinese Traditional Medicine (Other), 3201 Hospital in Hanzhong (Other), Sir Run Run Shaw Hospital (Other), Chengdu Fifth People's Hospital (Other), First People 's Hospital of Changsha (Other), Chongqing Jiangjin Central Hospital (Other), the Affiliated hospital of Guilin medical university, China (Other), Jiangxi People 's Hospital (Other), Chinese People 's Liberation Army Navy Anqing Hospital (Other), The Affiliated Hospital of Inner Mongolia Medical University (Other), Yancheng Dafeng People 's Hospital (Other), ShuGuang Hospital (Other), The First Affiliated Hospital of the Fourth Military Medical University (Other), Taizhou Hospital (Other), The Second Affiliated Hospital of Harbin Medical University (Other), Third Affiliated Hospital of Xinjiang Medical University (Other), First People 's Hospital of Kunming (Other), First People 's Hospital of Yunnan (Other), Pingxiang People 's Hospital (Other), Northern Jiangsu People 's Hospital (Other), Xiangya Hospital of Central South University (Other), Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other), Second Hospital of Jilin University (Other), The Second Economic Hospital of Xinjiang Uygur Autonomous Region (Other), Shanghai Zhongshan Hospital (Other)

505

Enrollment

Location

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Function

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

505 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
COPD group COPD patients
Asthma group Asthma patients
Health group Healthy volunteers

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital
Xinjiang Autonomous Region People 's Hospital
Cangzhou Central Hospital
Chengdu sixth People 's Hospital
Chengde Central Hospital
Beijing Fengtai Hospital
The Affiliated Hospital of Medical College, Ningbo University
Changzhi Medical College
Beijing Boai Hospital
Wuhu Hospital of Chinese Traditional Medicine
The First People's Hospital of Jingzhou
Fujian Provincial Hospital
Harbin Zhongshan Asthma Hospital
Rizhao Hospital of Chinese Traditional Medicine
3201 Hospital in Hanzhong
Sir Run Run Shaw Hospital
Chengdu Fifth People's Hospital
First People 's Hospital of Changsha
Chongqing Jiangjin Central Hospital
the Affiliated hospital of Guilin medical university, China
Jiangxi People 's Hospital
Chinese People 's Liberation Army Navy Anqing Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Yancheng Dafeng People 's Hospital
ShuGuang Hospital
The First Affiliated Hospital of the Fourth Military Medical University
Taizhou Hospital
The Second Affiliated Hospital of Harbin Medical University
Third Affiliated Hospital of Xinjiang Medical University
First People 's Hospital of Kunming
First People 's Hospital of Yunnan
Pingxiang People 's Hospital
Northern Jiangsu People 's Hospital
Xiangya Hospital of Central South University
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Second Hospital of Jilin University
The Second Economic Hospital of Xinjiang Uygur Autonomous Region
Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03193879

Other Study ID Numbers:

2015CB553402

First Posted:

Jun 21, 2017

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking Union Medical College Hospital

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Sep 21, 2021