Chronic Obstructive Pulmonary DiseaseNCT02964117
Associations Between Air Pollutants Exposures and Respiratory System Study
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital.
Trial summary
Epidemiological investigations has suggested exposure to air pollution linked with respiratory disease, especially chronic obstructive pulmonary disease. However, the potential mechanisms of adverse effects remains scare. Read more about this study
- Who is it for?
- Ages 23 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jan 2016
- 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 23 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects including health volunteers and COPD patients,both of them without severe cardiopulmonary diseases and long-term residents in Beijing
Who may be able to join
- Long-term residents, aged >23 and <82 years
Who cannot join
- Severe cardiopulmonary diseases, active inflammatory diseases, cancer
About this study
Epidemiological investigations has suggested exposure to air pollution linked with respiratory disease, especially chronic obstructive pulmonary disease. However, the potential mechanisms of adverse effects remains scare. The present study will assess the association between air pollutants and respiratory related parameters to elucidate possible mechanisms.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Function indices were performed in peking university third hospital
Lung Function indices including FEV1(ml), FVC(ml),the ratio of FEV1/FVC et, al.. When we perform data analysis,these parameters will be expressed as the percentage of the predicted values based on the subject-specific sex, age,height and weight.
Measured: Repeated-measure study was conducted from November,2014 to January,2016,lung function was measured by every four months
Secondary outcomes (1)
Inflammation related biomarkers were measured by flow cytometry
Inflammation related factors including IL,TNFa et, al. all biomarkers units are pg/ml.
Measured: Repeated-measure study was conducted from November,2014 to January,2016,biomarkers were measured by every four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Bei He, Peking University Third Hospital
- Investigators
- Bei He, MD/Ph.D, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964117
- Sponsor's protocol ID
- Apers Study
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Air Pollutants Exposures and Respiratory System Study
- ClinicalTrials.gov ID
- NCT02964117
- Acronym / sponsor ID
- Apers Study
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Nov 2016 (estimated)
- 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.
Epidemiological investigations has suggested exposure to air pollution linked with respiratory disease, especially chronic obstructive pulmonary disease. However, the potential mechanisms of adverse effects remains scare. The present study will assess the association between air pollutants and respiratory related parameters to elucidate possible mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects including health volunteers and COPD patients,both of them without severe cardiopulmonary diseases and long-term residents in Beijing
Key inclusion criteria (1 listed)
- Long-term residents, aged >23 and <82 years
Key exclusion criteria (1 listed)
- Severe cardiopulmonary diseases, active inflammatory diseases, cancer
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
Lung Function indices were performed in peking university third hospital
Time frame: Repeated-measure study was conducted from November,2014 to January,2016,lung function was measured by every four months
Lung Function indices including FEV1(ml), FVC(ml),the ratio of FEV1/FVC et, al.. When we perform data analysis,these parameters will be expressed as the percentage of the predicted values based on the subject-specific sex, age,height and weight.
1 secondary outcome
Inflammation related biomarkers were measured by flow cytometry
Time frame: Repeated-measure study was conducted from November,2014 to January,2016,biomarkers were measured by every four months
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 15 Nov 2016.
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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.
Bei He, MD/Ph.D study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital.
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 1 inclusion and 1 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Lung Function indices were performed in peking university third hospital (time frame: Repeated-measure study was conducted from November,2014 to January,2016,lung function was measured by every four months). 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 15 Nov 2016.