Pulmonary Disease, Chronic ObstructiveNCT00618137
Inert Dusts and Pathology of Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample of workers from the greater Vienna area
Who may be able to join
- COPD °0-III
- Workers of the greater Vienna Area
- Current smokers or ex-smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pulmonary Medicine, Medical University of Vienna
Vienna, A-1090
About this study
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
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.
Read the 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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, Gene expression profiling, Inert dusts, Natural course, Prospective assessment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Ziesche, Medical University of Vienna
- Investigators
- Lutz H Block, MD, Principal investigator, Medical University of ViennaRolf Ziesche, MD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618137
- Sponsor's protocol ID
- COPD-AUVA
- Status last verified
- Aug 2012
- First submitted
- 5 Feb 2008
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33524306
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00618137
- Acronym / sponsor ID
- COPD-AUVA
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, Gene expression profiling, Inert dusts, Natural course, Prospective assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of workers from the greater Vienna area
Key inclusion criteria (3 listed)
- COPD °0-III
- Workers of the greater Vienna Area
- Current smokers or ex-smokers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Derived from this study: PubMed 33524306Samaha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lutz H Block, MD principal investigator
Medical University of Vienna
Rolf Ziesche, MD study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.