Clinical trial NCT03193879: Effects of Particulate Matter on the Pulmonary Function and Acute Exacerbation of COPD and Asthma
Official title: Effects of Particulate Matter on the Lung Function and Acute Exacerbation of COPD and Asthma Patients--A Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Function
Keywords: Pulmonary function
Particulate matter
COPD
Asthma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Xinjiang Autonomous Region People 's Hospital
name: Cangzhou Central Hospital
name: Chengdu sixth People 's Hospital
name: Chengde Central Hospital
name: Beijing Fengtai Hospital
name: The Affiliated Hospital of Medical College, Ningbo University
name: Changzhi Medical College
name: Beijing Boai Hospital
name: Wuhu Hospital of Chinese Traditional Medicine
name: The First People's Hospital of Jingzhou
name: Fujian Provincial Hospital
name: Harbin Zhongshan Asthma Hospital
name: Rizhao Hospital of Chinese Traditional Medicine
name: 3201 Hospital in Hanzhong
name: Sir Run Run Shaw Hospital
name: Chengdu Fifth People's Hospital
name: First People 's Hospital of Changsha
name: Chongqing Jiangjin Central Hospital
name: the Affiliated hospital of Guilin medical university, China
name: Jiangxi People 's Hospital
name: Chinese People 's Liberation Army Navy Anqing Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Yancheng Dafeng People 's Hospital
name: ShuGuang Hospital
name: The First Affiliated Hospital of the Fourth Military Medical University
name: Taizhou Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Third Affiliated Hospital of Xinjiang Medical University
name: First People 's Hospital of Kunming
name: First People 's Hospital of Yunnan
name: Pingxiang People 's Hospital
name: Northern Jiangsu People 's Hospital
name: Xiangya Hospital of Central South University
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Second Hospital of Jilin University
name: The Second Economic Hospital of Xinjiang Uygur Autonomous Region
name: Shanghai Zhongshan Hospital
First posted: 2017-06-21
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinic-based population

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in spirometry (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure doses of PM.
timeFrame: 2 years
Secondary outcomes:
measure: Change in morbidity of acute exacerbation in COPD and asthma patients in response to different exposure doses of PM.
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: