- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037828
Exhaled Breathing Condensate (EBC) Features and Lung Function Decline in Chinese Adults
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Cheng Zhang, AR, MD
- Email: zhangcheng033@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Recruiting
- Peking Universtiy First Hospital
-
Contact:
- Zhou Tianyu, PHD
- Email: zty2712@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
1. FIRST STEP:
Case Group:
Inclusion criteria
- 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;
- 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
a. 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.
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;
- 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;
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein biomarkers of EBC between COPD patients and healthy individuals
Time Frame: 1 year
|
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.
|
1 year
|
Blood biomarkers between COPD patients and healthy individuals
Time Frame: 1 year
|
Peripheral blood will be collected.
Plasma and PBMC will be extracted and stored respectively.
|
1 year
|
Blood biomarkers predicting rapid decline of lung function
Time Frame: 4 year
|
Peripheral blood will be collected.
Plasma and PBMC will be extracted and stored respectively.
|
4 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guangfa Wang, MD, PHD, Peking Universtiy First Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUCRP201303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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