Clinical trial NCT00727714: Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study
Official title: Circulating Inflammatory Markers, Exhaled NO and Lung Function in Cement Production Workers; a Cross-shifts Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Keywords: Cement dust exposure
Cross-shift study
Lung function indices
Exhaled nitric oxide
Serum inflammatory markers
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Rikshospitalet University Hospital
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2008-08-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All employees of two Norwegian cement production plants are invited to participate.

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

* Employees from a Norwegian cement production plant

Exclusion Criteria:

* Exhaled nitric oxide measurements: smokers
* Substantial previous work in quarry or as a miner

Primary outcomes:
measure: Changes in Lung Function Measurements During One Work Shift (6-8h)
timeFrame: baseline and 6-8h
Secondary outcomes:
measure: Changes in FeNO Measurements During One Shift (6-8h)
timeFrame: baseline and 6-8h
measure: Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)
timeFrame: Baseline and 6-8h
measure: Changes in FeNO Measurements Between Baseline (0h) and 32 h
timeFrame: 0-32h
measure: Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h
timeFrame: 0-32h
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark HF
Study officials:
affiliation: Rikshospitalet University Hospital
name: Johny Kongerud, MD, PhD
role: STUDY_CHAIR
affiliation: National Institute of occupational Health, NIOH
name: Helge Kjuus, MD, PhD
role: STUDY_CHAIR
affiliation: National Institute of occupational Health, NIOH
name: Marit Skogstad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fell 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.
citation: Ali 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.
citation: Larsson 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.
citation: Raulf-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.
citation: Miller 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.
citation: Macintyre 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.
citation: American 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.