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

NCT02037828 | Unknown DMC

• 1 other identifier: PUCRP201303
• Study Type: observational
• Target: 2,440
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; biomarker; EBC; FEV1

Outcome Measures

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.

  4 years

Secondary Outcomes (3)

• Protein biomarkers of EBC between COPD patients and healthy individuals

  1 year

• Blood biomarkers between COPD patients and healthy individuals

  1 year

• Blood biomarkers predicting rapid decline of lung function

  4 year

Study Arms (4)

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

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age from 40 to 75 year olds; gender is not limited.
• Stable COPD

You may not qualify if:

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• 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:
• age from 40 to 75 year olds; gender is not limited.
• FEV1 /forced vital capacity (FVC)\> 70% after inhaling bronchodilators;
• 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.)
• 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.
• with known other chronic respiratory diseases except COPD (such as asthma, tuberculosis, bronchiectasis, interstitial lung disease, occupational lung diseases, sarcoidosis, lung cancer, et al);

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking Universtiy First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. EBC 2. Peripheral blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangfa Wang, MD, PHD

  Peking Universtiy First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Zhang, AR, MD

CONTACT

zhangcheng033@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro.

Study Record Dates

• First Submitted: December 25, 2013
• First Posted: January 16, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

CN (1)