Airway ObstructionLISNCT00727714
Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study
An observational study of Airway Obstruction, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- How many people
- 95 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2008to Jan 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All employees of two Norwegian cement production plants are invited to participate.
Who may be able to join
- Employees from a Norwegian cement production plant
Who cannot join
- Exhaled nitric oxide measurements: smokers
- Substantial previous work in quarry or as a miner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study
The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
Read the detailed description
OBJECTIVE:
Cement dust is suspected to be one of the main factors causing increased mortality among workers not only in the cement production industry, but also in the construction industry worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
METHODS:
All employees from Norwegian cement plants, are invited to participate. The workers will perform spirometry, single-breath determination of carbon monoxide uptake, blood samples before and after a working shift of 6-8 hours, and again after 24 hours. Information on respiratory symptoms, allergy and former respiratory disease as well as exposure information will be given on a self-reported questionnaire. Changes in lung function indices, nitric oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be measured in non-smokers. We will compare cement dust exposed workers with low-level or non-exposed workers (controls).
- Conditions
- Airway Obstruction
- Keywords
- Cement dust exposure, Cross-shift study, Lung function indices, Exhaled nitric oxide, Serum inflammatory markers
- Medical subject headings
- Airway Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Lung Function Measurements During One Work Shift (6-8h)
Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity
Measured: baseline and 6-8h
Secondary outcomes (4)
Changes in FeNO Measurements During One Shift (6-8h)
Measured: baseline and 6-8h
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)
Measured: Baseline and 6-8h
Changes in FeNO Measurements Between Baseline (0h) and 32 h
Measured: 0-32h
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h
Measured: 0-32h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Rikshospitalet University Hospital, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Anne Kristin M. Fell, Sykehuset Telemark
- Investigators
- Johny Kongerud, MD, PhD, Study chair, Rikshospitalet University HospitalHelge Kjuus, MD, PhD, Study chair, National Institute of occupational Health, NIOHMarit Skogstad, MD, PhD, Principal investigator, National Institute of occupational Health, NIOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727714
- Sponsor's protocol ID
- STHF 5690.11, REK S-08083a
- Acronym
- LIS
- Status last verified
- Apr 2016
- First submitted
- 30 Jul 2008
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The individual data is no longer available, due to regulations in Norway requiering individual data to be deleted 5 years after the study was compleeted.
Publications
Abrons HL, Petersen MR, Sanderson WT, Engelberg AL, Harber P. Symptoms, ventilatory function, and environmental exposures in Portland cement workers. Br J Ind Med. 1988 Jun;45(6):368-75. doi: 10.1136/oem.45.6.368.
PubMed 3260798Fell AK, Thomassen TR, Kristensen P, Egeland T, Kongerud J. Respiratory symptoms and ventilatory function in workers exposed to portland cement dust. J Occup Environ Med. 2003 Sep;45(9):1008-14. doi: 10.1097/01.jom.0000083036.56116.9d.
PubMed 14506344Ali BA, Ballal SG, Albar AA, Ahmed HO. Post-shift changes in pulmonary function in a cement factory in eastern Saudi Arabia. Occup Med (Lond). 1998 Nov;48(8):519-22. doi: 10.1093/occmed/48.8.519.
PubMed 10024727Larsson K. Aspects on pathophysiological mechanisms in COPD. J Intern Med. 2007 Sep;262(3):311-40. doi: 10.1111/j.1365-2796.2007.01837.x.
PubMed 17697154Raulf-Heimsoth M, Pesch B, Schott K, Kappler M, Preuss R, Marczynski B, Angerer J, Rihs HP, Hahn JU, Merget R, Bruning T. Irritative effects of fumes and aerosols of bitumen on the airways: results of a cross-shift study. Arch Toxicol. 2007 Jan;81(1):35-44. doi: 10.1007/s00204-006-0115-z. Epub 2006 May 19.
PubMed 16710697Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.
PubMed 16204605American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
PubMed 15817806
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study
- ClinicalTrials.gov ID
- NCT00727714
- Acronym / sponsor ID
- LIS / STHF 5690.11, REK S-08083a
- Conditions
- Airway Obstruction
- Keywords
- Cement dust exposure, Cross-shift study, Lung function indices, Exhaled nitric oxide, Serum inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Rikshospitalet University Hospital, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Posted 20 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
Detailed description
OBJECTIVE:
Cement dust is suspected to be one of the main factors causing increased mortality among workers not only in the cement production industry, but also in the construction industry worldwide. Our aim is to examine possible changes in lung function, nitric oxide levels and systemic inflammatory markers in cement dust exposed workers, during one shift (6-8 hours).
METHODS:
All employees from Norwegian cement plants, are invited to participate. The workers will perform spirometry, single-breath determination of carbon monoxide uptake, blood samples before and after a working shift of 6-8 hours, and again after 24 hours. Information on respiratory symptoms, allergy and former respiratory disease as well as exposure information will be given on a self-reported questionnaire. Changes in lung function indices, nitric oxide levels and serum inflammatory markers will be calculated. Nitric oxide will only be measured in non-smokers. We will compare cement dust exposed workers with low-level or non-exposed workers (controls).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All employees of two Norwegian cement production plants are invited to participate.
Key inclusion criteria (1 listed)
- Employees from a Norwegian cement production plant
Key exclusion criteria (2 listed)
- Exhaled nitric oxide measurements: smokers
- Substantial previous work in quarry or as a miner
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
Changes in Lung Function Measurements During One Work Shift (6-8h)
Time frame: baseline and 6-8h
Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity
4 secondary outcomes
Changes in FeNO Measurements During One Shift (6-8h)
Time frame: baseline and 6-8h
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)
Time frame: Baseline and 6-8h
Changes in FeNO Measurements Between Baseline (0h) and 32 h
Time frame: 0-32h
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h
Time frame: 0-32h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3260798Abrons HL, Petersen MR, Sanderson WT, Engelberg AL, Harber P. Symptoms, ventilatory function, and environmental exposures in Portland cement workers. Br J Ind Med. 1988 Jun;45(6):368-75. doi: 10.1136/oem.45.6.368.
- Background: PubMed 14506344Fell AK, Thomassen TR, Kristensen P, Egeland T, Kongerud J. Respiratory symptoms and ventilatory function in workers exposed to portland cement dust. J Occup Environ Med. 2003 Sep;45(9):1008-14. doi: 10.1097/01.jom.0000083036.56116.9d.
- Background: PubMed 10024727Ali BA, Ballal SG, Albar AA, Ahmed HO. Post-shift changes in pulmonary function in a cement factory in eastern Saudi Arabia. Occup Med (Lond). 1998 Nov;48(8):519-22. doi: 10.1093/occmed/48.8.519.
- Background: PubMed 17697154Larsson K. Aspects on pathophysiological mechanisms in COPD. J Intern Med. 2007 Sep;262(3):311-40. doi: 10.1111/j.1365-2796.2007.01837.x.
- Background: PubMed 16710697Raulf-Heimsoth M, Pesch B, Schott K, Kappler M, Preuss R, Marczynski B, Angerer J, Rihs HP, Hahn JU, Merget R, Bruning T. Irritative effects of fumes and aerosols of bitumen on the airways: results of a cross-shift study. Arch Toxicol. 2007 Jan;81(1):35-44. doi: 10.1007/s00204-006-0115-z. Epub 2006 May 19.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 16204605Macintyre N, Crapo RO, Viegi G, Johnson DC, van der Grinten CP, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, Gustafsson P, Hankinson J, Jensen R, McKay R, Miller MR, Navajas D, Pedersen OF, Pellegrino R, Wanger J. Standardisation of the single-breath determination of carbon monoxide uptake in the lung. Eur Respir J. 2005 Oct;26(4):720-35. doi: 10.1183/09031936.05.00034905. No abstract available.
- Background: PubMed 15817806American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
- Individual participant dataSharing planned: No. The individual data is no longer available, due to regulations in Norway requiering individual data to be deleted 5 years after the study was compleeted.
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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.
Johny Kongerud, MD, PhD study chair
Rikshospitalet University Hospital
Helge Kjuus, MD, PhD study chair
National Institute of occupational Health, NIOH
Marit Skogstad, MD, PhD principal investigator
National Institute of occupational Health, NIOH
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 Airway Obstruction, run by Sykehuset Telemark at 1 site in Norway.
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 1 inclusion and 2 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 20 May 2016. 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 Norway. 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?
Yes. Results are posted in the registry (first posted 20 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Changes in Lung Function Measurements During One Work Shift (6-8h) (time frame: baseline and 6-8h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727714, which also lists 8 linked publications.
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 20 May 2016.