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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00455377
Other study ID # STHF 5690.11, REK S-00166
Secondary ID
Status Completed
Phase N/A
First received March 30, 2007
Last updated June 12, 2013
Start date March 2007
Est. completion date December 2008

Study information

Verified date June 2013
Source Sykehuset Telemark
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

The aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i Norway.


Description:

OBJECTIVE: Former studies have presented conflicting data on the association between exposure to Portland cement dust and respiratory effects. Our goal is to examine inflammation in the airways and in peripheral blood in subjects exposed to cement-dust.

METHODS: All non smoking, dust exposed, workers from one department in the largest cement plant in Norway, are invited to participate. The workers will perform spirometry and induced sputum (IS) after a period of regular work with cement dust exposure, and again after a minimum of 5 days without exposure. Information on respiratory symptoms, allergy and former respiratory disease will be given on a self-reported questionnaire. IS was performed and processed as described by Pin et al. Differential cell counts will be carried out. Inflammatory markers in induced sputum and in peripheral blood will be measured. We want to use a crossover design were the cases are used as their own controls, but we will also include external controls.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

- Cement dust exposure

- Non-smoker or ex-smoker >3 years

Exclusion Criteria:

- Infectious disease during the last 3 weeks

- Chronic airway disease

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Sykehuset Telemark Skien Telemark

Sponsors (3)

Lead Sponsor Collaborator
Sykehuset Telemark Helse Sor-Ost, Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Fell AK, Sikkeland LI, Svendsen MV, Kongerud J. Airway inflammation in cement production workers. Occup Environ Med. 2010 Jun;67(6):395-400. doi: 10.1136/oem.2009.047852. Epub 2009 Oct 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of neutrophile cells in induced sputum A significantly higher percentage of neutrophils was observed in induced sputum samples from cement production workers collected during an exposed period compared with a nonexposed period and compared with external controls. Before and after a period of exposure No
Primary Concentration of Interleukin 1beta in induced sputum The concentration of Interleukin 1beta was higher in the sputum of workers during an exposed period than that of the office workers or the external controls. Before and after a period of exposure to cement production dust No
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