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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 505

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Clinic-based population

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
COPD group; COPD patients
Asthma group; Asthma patients
Health group; Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Xiangya Hospital of Central South University; Shanghai Zhongshan Hospital; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Sir Run Run Shaw Hospital; The Second Affiliated Hospital of Harbin Medical University; Cangzhou Central Hospital; Changzhi Medical College; Second Hospital of Jilin University; Xinjiang Autonomous Region People 's Hospital; Chengdu sixth People 's Hospital; Chengde Central Hospital; Beijing Fengtai Hospital; The Affiliated Hospital of Medical College, Ningbo University; 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; 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; 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; The Second Economic Hospital of Xinjiang Uygur Autonomous Region

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 18, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Asthma; COPD; Particulate matter; Pulmonary function
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2015CB553402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No