Exhaled Breathing Condensate (EBC) Features and Lung Function Decline in Chinese Adults

August 2, 2017 updated by: Guangfa Wang, Peking University First Hospital

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

Unknown

Detailed Description

Thus we designed this study. This study is divided into two parts: screening target biomarkers and identifying biomarkers.

  1. 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.
  2. 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

Observational

Enrollment (Anticipated)

2440

Contacts and Locations

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

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking Universtiy First Hospital
        • Contact:

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

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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:

  1. Case Group:

    Inclusion criteria

    1. age from 40 to 75 year olds; gender is not limited.
    2. Stable COPD
    3. Sign the informed consent with willingness of obeying the protocol. Exclusion criteria
    1. with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
    2. had been accepted lung lobectomy or transplantation;
    3. 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 );
    4. Alcoholism, drug or solvents addition;
    5. Acute exacerbation COPD patients (AECOPD)
  2. Control group:

Inclusion criteria According to age (+ / - 5 years), gender and smoking, to match healthy volunteers as the control group.

  1. age from 40 to 75 year olds; gender is not limited.
  2. FEV1 /forced vital capacity (FVC)> 70% after inhaling bronchodilators;
  3. 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

  1. age from 40 to 75 year olds; gender is not limited.
  2. have been living in the community for more than 1 years and no plan to move in the near 3 years
  3. FEV1 / FVC > 70% after inhaling bronchodilators;
  4. Sign the informed consent with willingness of obeying the protocol.

Exclusion criteria

  1. with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);
  2. had been accepted lung lobectomy or transplantation;
  3. 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 );
  4. Alcoholism, drug or solvents addition;

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

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

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

Collaborators

Investigators

  • Principal Investigator: Guangfa Wang, MD, PHD, Peking Universtiy First Hospital

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

June 1, 2014

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 25, 2013

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PUCRP201303

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

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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