Airway Obstruction
Conditions
Keywords
Cement dust exposure, Cross-shift study, Lung function indices, Exhaled nitric oxide, Serum inflammatory markers
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).
Interventions
None listed
Sponsors
Rikshospitalet University Hospital
National Institute for Occupational Safety and Health (NIOSH/CDC)
Sykehuset Telemark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Lung Function Measurements During One Work Shift (6-8h) | baseline and 6-8h | Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FeNO Measurements During One Shift (6-8h) | baseline and 6-8h |
| Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) | Baseline and 6-8h |
| Changes in FeNO Measurements Between Baseline (0h) and 32 h | 0-32h |
| Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h | 0-32h |
Countries
Norway
Participant flow
Recruitment details
95 workers from two cement plants in Norway (located in the small cities of in Brevik in South-Norway and Kjøpsvik in the North-Norway) were examined in the winter sesons in 2008 and 2009.
Pre-assignment details
The workers were required to be off work for at least two days before Medical examinations, then exposed to cement Production dust between 0 and 8 h and again between 24 and 32 h. Those not exposed in these periods were excluded. No unexposed controls were included, the participants were their own controls.
Participants by arm
| Arm | Count |
|---|---|
| Exposed Workers 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Exposed Workers |
|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 13 |
| BMI | 28 kg/m^2 STANDARD_DEVIATION 4 |
| duration of exposure | 16 years STANDARD_DEVIATION 13 |
| Fraction of exhaled nitric oxide (FeNO) | 14 parts per billion |
| height | 179 cm STANDARD_DEVIATION 7 |
| Inflammatory markers in blood IL-10 | 1.12 ng/litre |
| Inflammatory markers in blood IL-1B | 0.25 ng/litre |
| Region of Enrollment Norway | 95 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 88 Participants |
| Smoking Ex-smokers | 22 participants |
| Smoking Never-smokers | 34 participants |
| Smoking Smokers | 39 participants |
| Spirometry FEV1 | 3.92 Litres STANDARD_DEVIATION 0.81 |
| Spirometry FVC | 5.02 Litres STANDARD_DEVIATION 0.91 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 |
Outcome results
Primary
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
Time frame: baseline and 6-8h
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exposed Workers | Changes in Lung Function Measurements During One Work Shift (6-8h) | FVC | 4.99 Litres | Standard Deviation 0.97 |
| Exposed Workers | Changes in Lung Function Measurements During One Work Shift (6-8h) | FEV1 | 3.88 Litres | Standard Deviation 0.81 |
Secondary
Changes in FeNO Measurements Between Baseline (0h) and 32 h
Time frame: 0-32h
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exposed Workers | Changes in FeNO Measurements Between Baseline (0h) and 32 h | 12 ppb |
Secondary
Changes in FeNO Measurements During One Shift (6-8h)
Time frame: baseline and 6-8h
Population: Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exposed Workers | Changes in FeNO Measurements During One Shift (6-8h) | 14 ppb |
Secondary
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h
Time frame: 0-32h
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exposed Workers | Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h | IL-10 | 0.97 ng/Litre |
| Exposed Workers | Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h | IL-1B | 0.20 ng/Litre |
Secondary
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)
Time frame: Baseline and 6-8h
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exposed Workers | Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) | IL-1B | 0.23 ng/Litre |
| Exposed Workers | Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) | IL-10 | 0.91 ng/Litre |