Inert Dusts and Pathology of Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618137
• Other study ID #: COPD-AUVA
• Status: Completed
• Phase: N/A
• First received: February 5, 2008
• Last updated: August 23, 2012
• Start date: January 2007
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Austria	Department of Pulmonary Medicine, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria,