Biomarkers in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and
      mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the
      disease is chronic inflammation leading to narrowing of the small airways and thus impairment
      of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive
      to identify the regional heterogeneity of bronchial airflow obstruction in the small airways.

      The aim of this study is to evaluate whether there is a correlation between the sbN2-test,
      markers in exhaled air and the inflammatory cells in the small airways.
    

Detailed description: 
      The cornerstone of COPD is a chronic inflammation leading to narrowing of the small airways
      and thus impairment of lung function. Spirometry, the most frequently used pulmonary function
      test for diagnosing and monitoring disease, mostly reflects obstruction of the larger
      airways. The single breath N2-test, however, is more sensitive to identify the regional
      heterogeneity of bronchial airflow obstruction in the small airways, a main site of injury in
      COPD.

      The aim of this study is to evaluate whether there is a correlation between the sbN2-test,
      markers in exhaled air and the inflammatory cells in the small airways.

      This protocol describes a cross-sectional, explorative trial in at least 16 patients with
      COPD (up to GOLD III) and 8 patients without COPD who are scheduled for surgical resection
      for primary lung cancer. Immunohistological methods will be used to characterize the airways
      (large and small) inflammation pattern in macroscopically normal tissue containing small and
      large airways collected from sites distant from the tumor. Inflammatory markers will be
      measured in exhaled breath (exhaled breath condensate, exhaled NO) and be correlated to the
      sbN2 test. Breath patterns before and after lung cancer surgery will be assessed by the
      electronic nose and differential mobility spectrometry.

      We hypothesize that the sbN2-test and inflammatory markers in exhaled breath reflect changes
      at peripheral tissue level. Therefore the results of the present study would lead to
      validation of these non-invasive tools for studies into the pathogenesis of obstructive lung
      disease, to increased knowledge about the relationship between airway inflammation and small
      airways obstruction, and may provide further support for the small airways as a specific
      target for inhaled drug delivery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with and without COPD scheduled for lung resection for lung cancer.
      
Biospecimen description: 
      blood
    
Keywords: COPD; Inflammation; Small airways