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

Pulmonary Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193879
• Other study ID #: 2015CB553402
• Status: Completed
• Start date: December 2015
• Est. completion date: September 2021

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Pulmonary Function

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (38)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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