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Status unknownNCT02037828Updated Aug 3, 2017

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

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Peking University First Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-03.

Sponsored by Peking University First Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,440
Ages
40 Years to 75 Years
Sex
All
01

Study 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. 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.

  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.
02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • biomarker
  • EBC
  • FEV1
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 2,440 is above the median of 150 across 638 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

  1. FIRST STEP:
  1. Case Group:

Inclusion criteria

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

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  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)
  1. 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

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;
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,440 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 years

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. Blood biomarkers between COPD patients and healthy individuals

    Peripheral blood will be collected. Plasma and PBMC will be extracted and stored respectively.

    Time frame: 1 year

  3. Blood biomarkers predicting rapid decline of lung function

    Peripheral blood will be collected. Plasma and PBMC will be extracted and stored respectively.

    Time frame: 4 year

07

Study locations

1 of 1 sites recruiting
  • Peking Universtiy First Hospital
    Beijing, Beijing 100034, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02037828
Lead sponsor
Peking University First Hospital
Collaborators
Peking University
Responsible party
Guangfa Wang (Pro., Peking University First Hospital) — Principal investigator
First posted
Jan 16, 2014
Start date
Jun 2014
Primary completion
Jun 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 3, 2017

Study contacts

Cheng Zhang, AR, MD
Contact
zhangcheng033@163.com
Guangfa Wang, MD, PHD
principal investigator · Peking Universtiy First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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