Lung Function and Airway Inflammation in Portland Cement Workers

Airway Inflammation Clinical Trial

— SPUTUM  

Official title:

Airway Inflammation in Cement Dust Exposed Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455377
• Other study ID #: STHF 5690.11, REK S-00166
• 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

• Airway Inflammation
• Cement Dust Exposure
• Inflammation
• Peripheral Blood Inflammation Markers

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