Inert Dusts and Pathology of Chronic Obstructive Pulmonary Disease

Medical University of Vienna

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Other

Identifiers

NCT00618137

COPD-AUVA

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• COPD °0-III
• Workers of the greater Vienna Area
• Current smokers or ex-smokers

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 infection, in particular bronchiectasis
• Cancer