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

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ClinicalTrials.gov Identifier: NCT03193879
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborators:
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
Affiliated Peace Hospital of 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
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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 : December 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  1. Change in spirometry (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure doses of PM. [ Time Frame: 2 years ]
    Spirometry will be assessed at baseline and through study completion, an average of 2 years.


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


Biospecimen Retention:   Samples With DNA
Biological specimens are preserved in serum, plasma, and leukocytes


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Clinic-based population
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193879


Contacts
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Contact: Kai-Feng Xu, M.D. 86-10-69155039 xukf@pumch.cn
Contact: Xinlun Tian, M.D. 86-10-69155039 tianxl@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Kai-Feng Xu, M.D.    86-10-69155039    xukf@pumch.cn   
Contact: Xinlun Tian, M.D.    86-10-69155039    xinlun_t@sina.com   
Sub-Investigator: Xinlun Tian, M.D.         
Principal Investigator: Kai-Feng Xu, M.D.         
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
Affiliated Peace Hospital of 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

Additional Information:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03193879     History of Changes
Other Study ID Numbers: 2015CB553402
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:
Pulmonary function
Particulate matter
COPD
Asthma