Chronic Obstructive Pulmonary Disease Clinical Trial
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.
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.
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