Chronic Obstructive Pulmonary DiseaseNCT02037828
Exhaled Breathing Condensate (EBC) Features and Lung Function Decline in Chinese Adults
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University First Hospital at 1 site in China.
Trial summary
Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 2,440 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2019
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The FIRST STEP of study will be a outpatient based case-control study. 20 stable COPD patients and 20 healthy individuals will be recruited. The SECOND STEP of study will be a community based, multi-center，prospective nested case-control designed, which including a total of 24OO study subjects, it will focus on two different communities, which are Shi Cha Hai community, De Sheng Community in Beijing
Who may be able to join
- age from 40 to 75 year olds; gender is not limited.
- Stable COPD
- Sign the informed consent with willingness of obeying the protocol. Exclusion criteria
- <!-- -->
- with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
- had been accepted lung lobectomy or transplantation;
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- be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
- Alcoholism, drug or solvents addition;
- Acute exacerbation COPD patients (AECOPD)
- Control group:
- Inclusion criteria According to age (+ / - 5 years), gender and smoking, to match healthy volunteers as the control group.
- age from 40 to 75 year olds; gender is not limited.
- FEV1 /forced vital capacity (FVC)> 70% after inhaling bronchodilators;
- Sign the informed consent with willingness of obeying the protocol. Exclusion criteria
- with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al); b. had been accepted lung lobectomy or transplantation; c. be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al ); d. Alcoholism, drug or solvents addition; e. Acute respiratory infection in 4 weeks (rhinitis, pharyngitis, acute tracheobronchitis, pneumonia, etc.)
- 2.SECOND STEP: nested case-control study Inclusion criteria
- age from 40 to 75 year olds; gender is not limited.
- have been living in the community for more than 1 years and no plan to move in the near 3 years
- FEV1 / FVC > 70% after inhaling bronchodilators;
- Sign the informed consent with willingness of obeying the protocol.
Who cannot join
- with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
- had been accepted lung lobectomy or transplantation;
- be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
- Alcoholism, drug or solvents addition;
Trial locations and contacts
1 site in 1 country.
Cheng Zhang, AR, MD contact
China1 site, 1 recruiting
- Recruiting
Peking Universtiy First Hospital
Beijing, Beijing Municipality, 100034
Zhou Tianyu, PHD, zty2712@hotmail.com
About this study
Official title: The Screening and Confirmation of Protein Markers Which Can Predict the Decline of Lung Function of Chinese Adults in EBC (Exhaled Breathing Condensate )
Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis. Previous studies have found that accelerated loss of forced expiratory volume in 1 second (FEV1.0) in an individual is considered an indicator of developing COPD. This functional predictive system, due to lower sensitivity, is very difficult to discover high-risk population and earlier stage of the disease. The inflammation occurs earlier than the lung function impairment. Therefore, early detection of the inflammation may theoretically predict the occurrence of COPD and thus may guide early intervention.
Proteomics techniques and protein chip techniques provides us high throughput screening method to figure out characteristic inflammatory or metabolic markers of a diseases. It can be used for searching the biomarkers relating to lung function loss. EBC is collected from exhaled gas and is a good non-invasive method for exploring the pathologic process of the airways.
Thus we designed this study to identify potential biomarkers associated with rapid lung function decline. This study is divided into two parts: 1) screening potential biomarkers between stable COPD and healthy individuals; 2) verifying significant biomarkers of first part in a community-based nested case-control population for 2 years.
Read the detailed description
Thus we designed this study. This study is divided into two parts: screening target biomarkers and identifying biomarkers.
- The FIRST STEP is a Case-control study to find target biomarkers. 20 COPD patients and 20 controls are to be enrolled in the study and their EBC and blood are collected. Proteomics techniques and protein chip techniques are to be used to screen COPD specific biomarkers in EBC.
- The SECOND STEP is a community-based nested case-control study to make sure whether the significant biomarkers in first part can predict rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects. EBC and blood are collected at the baseline and followed up for two years. Case group is defined as subjects with rapid decline of lung function and new COPD patients. Control group is selected according to 1:1 matching with age and gender.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, biomarker, EBC, FEV1
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Stable COPD in STEP1 | no intervention | |
| Control in STEP 1 | no intervention | |
| Case group in STEP 2 | no intervention | |
| Control group in STEP2 | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein biomarkers in EBC predicting rapid decline of lung function
The study(second part) is to identify the biomarkers screened from the first step and make sure which is associated with rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects.
Measured: 4 years
Secondary outcomes (3)
Protein biomarkers of EBC between COPD patients and healthy individuals
The first part of study is to screen target biomarkers. 20 COPD patients and 20 controls are to be enrolled in the study and their EBC are to reserved. Proteomics techniques and protein chip techniques were used to screening COPD specific biomarkers.
Measured: 1 year
Blood biomarkers between COPD patients and healthy individuals
Peripheral blood will be collected. Plasma and PBMC will be extracted and stored respectively.
Measured: 1 year
Blood biomarkers predicting rapid decline of lung function
Peripheral blood will be collected. Plasma and PBMC will be extracted and stored respectively.
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Guangfa Wang, Peking University First Hospital
- Investigators
- Guangfa Wang, MD, PHD, Principal investigator, Peking Universtiy First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037828
- Sponsor's protocol ID
- PUCRP201303
- Status last verified
- Aug 2017
- First submitted
- 25 Dec 2013
- Last updated
- 3 Aug 2017
- 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 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Screening and Confirmation of Protein Markers Which Can Predict the Decline of Lung Function of Chinese Adults in EBC (Exhaled Breathing Condensate )
- ClinicalTrials.gov ID
- NCT02037828
- Acronym / sponsor ID
- PUCRP201303
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, biomarker, EBC, FEV1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,440 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Jun 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Jan 2014 (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.
Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis. Previous studies have found that accelerated loss of forced expiratory volume in 1 second (FEV1.0) in an individual is considered an indicator of developing COPD. This functional predictive system, due to lower sensitivity, is very difficult to discover high-risk population and earlier stage of the disease. The inflammation occurs earlier than the lung function impairment. Therefore, early detection of the inflammation may theoretically predict the occurrence of COPD and thus may guide early intervention.
Proteomics techniques and protein chip techniques provides us high throughput screening method to figure out characteristic inflammatory or metabolic markers of a diseases. It can be used for searching the biomarkers relating to lung function loss. EBC is collected from exhaled gas and is a good non-invasive method for exploring the pathologic process of the airways.
Thus we designed this study to identify potential biomarkers associated with rapid lung function decline. This study is divided into two parts: 1) screening potential biomarkers between stable COPD and healthy individuals; 2) verifying significant biomarkers of first part in a community-based nested case-control population for 2 years.
Detailed description
Thus we designed this study. This study is divided into two parts: screening target biomarkers and identifying biomarkers.
- The FIRST STEP is a Case-control study to find target biomarkers. 20 COPD patients and 20 controls are to be enrolled in the study and their EBC and blood are collected. Proteomics techniques and protein chip techniques are to be used to screen COPD specific biomarkers in EBC.
- The SECOND STEP is a community-based nested case-control study to make sure whether the significant biomarkers in first part can predict rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects. EBC and blood are collected at the baseline and followed up for two years. Case group is defined as subjects with rapid decline of lung function and new COPD patients. Control group is selected according to 1:1 matching with age and gender.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stable COPD in STEP1 | – | –no intervention |
| Control in STEP 1 | – | –no intervention |
| Case group in STEP 2 | – | –no intervention |
| Control group in STEP2 | – | –no intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The FIRST STEP of study will be a outpatient based case-control study. 20 stable COPD patients and 20 healthy individuals will be recruited. The SECOND STEP of study will be a community based, multi-center，prospective nested case-control designed, which including a total of 24OO study subjects, it will focus on two different communities, which are Shi Cha Hai community, De Sheng Community in Beijing
Key inclusion criteria (20 listed)
- <!-- -->
- Control group:
- Inclusion criteria According to age (+ / - 5 years), gender and smoking, to match healthy volunteers as the control group.
- age from 40 to 75 year olds; gender is not limited.
- FEV1 /forced vital capacity (FVC)> 70% after inhaling bronchodilators;
Key exclusion criteria (4 listed)
- with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
- had been accepted lung lobectomy or transplantation;
- be ill with severe, or uncontrolled systemic diseases other than COPD (such as psychiatry diseases, chronic liver diseases, heart failure, auto-immunity diseases, chronic renal diseases, et al );
- Alcoholism, drug or solvents addition;
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
Protein biomarkers in EBC predicting rapid decline of lung function
Time frame: 4 years
The study(second part) is to identify the biomarkers screened from the first step and make sure which is associated with rapid decline of lung function. The study will be a community based, multicenter prospective cohort designed, which including a total of 2,400 study subjects.
3 secondary outcomes
Protein biomarkers of EBC between COPD patients and healthy individuals
Time frame: 1 year
Blood biomarkers between COPD patients and healthy individuals
Time frame: 1 year
Blood biomarkers predicting rapid decline of lung function
Time frame: 4 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- 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.
Cheng Zhang, AR, MD contact
Guangfa Wang, MD, PHD principal investigator
Peking Universtiy First Hospital
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 Chronic Obstructive Pulmonary Disease, run by Peking University First 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 20 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Zhang, AR, MD (zhangcheng033@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein biomarkers in EBC predicting rapid decline of lung function (time frame: 4 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 3 Aug 2017.