Pulmonary FunctionNCT03193879
Effects of Particulate Matter on the Pulmonary Function and Acute Exacerbation of COPD and Asthma
An observational study of Pulmonary Function, run by Peking Union Medical College Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Function
- How many people
- 505 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Sep 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinic-based population
Who may be able to join
- COPD patients: clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70.
- 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.
- Asthma combined with COPD (ACOS) patients: patients with ACOS are included in asthma group.
- Healthy volunteers: No smoking history, or have quit smoking at least 5 years. Chest X-ray show no abnormality.
- Information consent form should be signed before entering the study.
Who cannot join
- The latest severe acute attack occurred within 4 weeks:
- Severe acute attack: status asthmaticus or acute exacerbation of COPD leading to consultation, emergency treatment，hospitalization, or glucocorticoid treatment（oral/i.v).
- 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.
- Any history of acute/chronic respiratory diseases other than asthma and COPD, including lung cancer and pulmonary infection.
- 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.
- Left heart insufficiency, or malignant arrhythmia.
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- HIV positive.
- Acute cerebrovascular events within 3 months, including apoplexy, transient cerebral ischemia and acute coronary syndrome.
- Uncured malignant tumors.
- Addicted to drug or alcohol, or any history of psychiatric disorders.
- Breastfeeding, pregnancy or planning to be pregnant.
- Estimated lifetime less than 2 years due to underlying diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Function
- Keywords
- Pulmonary function, Particulate matter, COPD, Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD group | COPD patients | |
| Asthma group | Asthma patients | |
| Health group | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startDec 2015
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- 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, Changzhi Medical College, Beijing Boai Hospital, Wuhu County Traditional Chinese Medicine Hospital, 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, Changsha First Hospital, Chongqing Jiangjin Central Hospital, 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, The 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193879
- Sponsor's protocol ID
- 2015CB553402
- Status last verified
- Sep 2021
- First submitted
- 14 Jun 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Particulate Matter on the Lung Function and Acute Exacerbation of COPD and Asthma Patients--A Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT03193879
- Acronym / sponsor ID
- 2015CB553402
- Conditions
- Pulmonary Function
- Keywords
- Pulmonary function, Particulate matter, COPD, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- 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, Changzhi Medical College, Beijing Boai Hospital, Wuhu County Traditional Chinese Medicine Hospital, 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, Changsha First Hospital, Chongqing Jiangjin Central Hospital, 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, The 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
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | –COPD patients |
| Asthma group | – | –Asthma patients |
| Health group | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic-based population
Key inclusion criteria (5 listed)
- COPD patients: clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70.
- 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.
- Asthma combined with COPD (ACOS) patients: patients with ACOS are included in asthma group.
- Healthy volunteers: No smoking history, or have quit smoking at least 5 years. Chest X-ray show no abnormality.
- Information consent form should be signed before entering the study.
Key exclusion criteria (12 listed)
- The latest severe acute attack occurred within 4 weeks:
- Any history of acute/chronic respiratory diseases other than asthma and COPD, including lung cancer and pulmonary infection.
- 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.
- Left heart insufficiency, or malignant arrhythmia.
- HIV positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change in morbidity of acute exacerbation in COPD and asthma patients in response to different exposure doses of PM.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Function, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spirometry (FEV1) of COPD, asthma patients and healthy volunteers in response to different exposure doses of PM. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.