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

September 18, 2021 updated by: Peking Union Medical College Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
COPD group
COPD patients
Asthma group
Asthma patients
Health group
Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 2 years
Spirometry will be assessed at baseline and through study completion, an average of 2 years.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 2 years
Patients will be followed up through study completion, an average of 2 years.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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