Inert Dusts and Pathology of Chronic Obstructive Pulmonary Disease

Longitudinal Assessment of Clinical and Molecular Pathology of Chronic Obstructive Lung Disease and the Possible Influence of Inert Dusts in Working Volunteers of the Greater Vienna Area

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive

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

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Department of Pulmonary Medicine, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Community sample of workers from the greater Vienna area

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Lutz H Block, MD, Medical University of Vienna; Study Director: Rolf Ziesche, MD, Medical University of Vienna

Publications and helpful links

General Publications

• Samaha E, Vierlinger K, Weinhappel W, Godnic-Cvar J, Nohammer C, Koczan D, Thiesen HJ, Yanai H, Fraifeld VE, Ziesche R. Expression Profiling Suggests Loss of Surface Integrity and Failure of Regenerative Repair as Major Driving Forces for Chronic Obstructive Pulmonary Disease Progression. Am J Respir Cell Mol Biol. 2021 Apr;64(4):441-452. doi: 10.1165/rcmb.2020-0270OC.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 5, 2008
• First Submitted That Met QC Criteria: February 5, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; Natural course; Gene expression profiling; Inert dusts; Prospective assessment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: COPD-AUVA