Trial Outcomes & Findings for Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study (NCT NCT00727714)

NCT ID: NCT00727714

Last Updated: 2016-05-20

Results Overview

Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity

• Recruitment status: COMPLETED
• Target enrollment: 95 participants
• Primary outcome timeframe: baseline and 6-8h
• Results posted on: 2016-05-20

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	95
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Lung Function and Inflammatory Markers in Cement Dust Exposed Workers: A Cross-shifts Study

Baseline characteristics by cohort

Measure	Exposed Workers n=95 Participants 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
Age, Continuous	41 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants
Region of Enrollment Norway	95 participants n=5 Participants
height	179 cm STANDARD_DEVIATION 7 • n=5 Participants
BMI	28 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants
Smoking Never-smokers	34 participants n=5 Participants
Smoking Ex-smokers	22 participants n=5 Participants
Smoking Smokers	39 participants n=5 Participants
duration of exposure	16 years STANDARD_DEVIATION 13 • n=5 Participants
Spirometry FVC	5.02 Litres STANDARD_DEVIATION 0.91 • n=5 Participants
Spirometry FEV1	3.92 Litres STANDARD_DEVIATION 0.81 • n=5 Participants
Fraction of exhaled nitric oxide (FeNO)	14 parts per billion n=5 Participants
Inflammatory markers in blood IL-1B	0.25 ng/litre n=5 Participants
Inflammatory markers in blood IL-10	1.12 ng/litre n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6-8h

Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity

Outcome measures

Measure	Exposed Workers n=93 Participants 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
Changes in Lung Function Measurements During One Work Shift (6-8h) FVC	4.99 Litres Standard Deviation 0.97
Changes in Lung Function Measurements During One Work Shift (6-8h) FEV1	3.88 Litres Standard Deviation 0.81

SECONDARY outcome

Timeframe: baseline and 6-8h

Population: Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements

Outcome measures

Measure	Exposed Workers n=58 Participants 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
Changes in FeNO Measurements During One Shift (6-8h)	14 ppb Interval 0.0 to 98.0

SECONDARY outcome

Timeframe: Baseline and 6-8h

Outcome measures

Measure	Exposed Workers n=88 Participants 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) IL-10	0.91 ng/Litre Interval 0.09 to 6.45
Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h) IL-1B	0.23 ng/Litre Interval 0.09 to 3.51

SECONDARY outcome

Timeframe: 0-32h

Outcome measures

Measure	Exposed Workers n=58 Participants 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
Changes in FeNO Measurements Between Baseline (0h) and 32 h	12 ppb Interval 0.0 to 82.0

SECONDARY outcome

Timeframe: 0-32h

Outcome measures

Measure	Exposed Workers n=88 Participants 95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h IL-1B	0.20 ng/Litre Interval 0.09 to 3.51
Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h IL-10	0.97 ng/Litre Interval 0.1 to 4.55

Adverse Events

Exposed Workers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anne Kristin M. Fell, MD, PhD

Telemark Hospital

Phone: +4735003106

Email: annfel@sthf.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place