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Completed

NCT Number: NCT00455377

Lung Function and Airway Inflammation in Portland Cement Workers

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

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Key information

Conditions

Airway Inflammation Cement Dust Exposure Peripheral Blood Inflammation Markers

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sykehuset Telemark

Skien, Telemark, N-3710, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cement dust exposure
  • Non-smoker or ex-smoker >3 years

Exclusion criteria

  • Infectious disease during the last 3 weeks
  • Chronic airway disease

Treatment and study plan

Primary outcomes

  1. Percentage of neutrophile cells in induced sputum

    Time frame: Before and after a period of exposure

    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.

  2. Concentration of Interleukin 1beta in induced sputum

    Time frame: Before and after a period of exposure to cement production dust

    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.

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Helse Sor-Ost
  • Rikshospitalet University Hospital

Registry information

Official study title

Airway Inflammation in Cement Dust Exposed Workers

Acronym: SPUTUM

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 3, 2007
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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