Inert Dusts and Pathology of Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The main objective of the study is the exploration of the natural course of COPD and its
      biological background. To this end, active workers without COPD and workers in functional
      classes GOLD 0-III are investigated by a combined clinical and molecular approach. The study
      has been designed as a prospective, intraindividual pilot in 160 male or female volunteers of
      the greater Vienna Area over a period of three years for each individual volunteer.
    

Detailed description: 
      Primary endpoint Combined assessment of clinical and molecular data obtained in three
      sequential study visits over an investigative period of 36 months for each individual; this
      includes, in particular, the identification of single and clustered gene functions connected
      to deterioration or stability of pulmonary function at the end of the observation period.

      Secondary endpoints Assessment of occupational and environmental exposure to primarily inert
      fine dusts in a random subset of the strata by means of 24h-measurement of quantity and
      quality of fine dust inhalation; Influence of intensified exposure to fine dusts due to
      occupational conditions; Development of lung function in the five different study groups (see
      below), particularly changes from one GOLD class into the next class;

      Definition of Study Groups:

      Group 1 (Control):

      Healthy volunteers, age 18 to 35 yr, never smokers (n=20).

      Group 2 (preferentially taxi or bus drivers; COPD °0):

      Working men/women, age 18 to 65 yr, preferentially taxi drivers or bus drivers or comparable
      occupational burden, current smokers or ex-smokers, with symptoms suggestive of COPD, yet
      regular lung function test at rest at the time of study entry, no signs of significant other
      diseases, in particular no signs of cardiovascular disease (n=35).

      Group 3 (preferentially taxi or bus drivers; COPD °I-III):

      Working men/women, preferentially taxi drivers or bus drivers or comparable occupational
      burden, age 35 to 65 yr, current smokers or ex-smokers, with symptoms of COPD, and abnormal
      lung function at rest at the time of study entry, no signs of significant other diseases, in
      particular no signs of cardiovascular disease (n=35).

      Group 4 (Welder; COPD °0):

      Working men/women, active welders or comparable occupational burden, age 35 to 65 yr, current
      smoker or ex-smoker, with symptoms suggestive of COPD, yet regular lung function test at
      rest, no signs of significant other diseases, in particular no signs of cardiovascular
      disease (n=35).

      Group 5 (Welder; COPD °I-III):

      Working men/women, active welders or comparable occupational burden, age 35 to 65 yr, current
      smoker or ex-smoker, with symptoms of COPD and abnormal lung function at rest at the time of
      study entry, no signs of significant other diseases, in particular no signs of cardiovascular
      disease (n=35).

      Exclusion criteria:

        -  COPD °IV

        -  Bronchial asthma

        -  Major cardiovascular diseases, in particular stroke and myocardial infarction with
           reduced cardiac function

        -  Age > 65 years

        -  Acute or chronic bronchial infections, in particular bronchiectasis

        -  Cancer

      Study investigations

      Visit 1 Visit 2 Visit 3 Clinical investigation x x x Blood drawing for laboratory testing x x
      x Spirometry x x x Body plethysmography x x x Spiro-Ergometry x x x CT Thorax x x x
      Bronchoscopy with transbronchial biopsy x x x Gene profiling x x x
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community sample of workers from the greater Vienna area
      
Biospecimen description: 
      Transbronchial lung biopsies Blood serum
    
Keywords: Chronic obstructive pulmonary disease; Gene expression profiling; Inert dusts; Natural course; Prospective assessment