Preventing Respiratory Health Problems in Bakery Employees (Baker2012)
The study is a follow-up of investigations done in the years 1999-2002 in bakery employees. The main purposes are to look at the associations between flour dust exposure and respiratory disease, and to find out the best ways to reduce the flour dust levels in the working environment.
Chronic Obstructive Lung Disease
|Study Design:||Observational Model: Cohort|
|Official Title:||Preventing Respiratory Health Problems in Bakery Employees.|
- Forced Exhaled Volume in one second (FEV1) [ Time Frame: Change/decline from 1999-2002 to 2012 ] [ Designated as safety issue: No ]The decline in FEV1 from 1999-2002 to 2012.
- Forced Vital Capacity (FVC) [ Time Frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months. ] [ Designated as safety issue: No ]Before and after salbutamol-inhalation. Post-bronchodilatory measurements of FEV1 and FVC to measure the prevalence of chronic obstructive lung disease in a cohort of bakery workers
- Inflammation markers in nasal lavage [ Time Frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months. ] [ Designated as safety issue: No ]Measurement in nasal lavage of inflammation markers (albumin, tryptase, eosinophilic cationic protein) when at work (field study)
- Specific IgE [ Time Frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months. ] [ Designated as safety issue: No ]In serum measurement of specific IgE to common airborne allergens, and allergens mainly found in bakeries
- Skin reaction to prick testing with allergen extracts [ Time Frame: Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months. ] [ Designated as safety issue: No ]Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)
Biospecimen Retention: Samples Without DNA
Serum, Nasal lavage fluid (without cells)
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Background and Methods:
Supported by the The Confederation of Norwegian Enterprise (CNBI) Working Environment Fund a follow-up study of 184 bakery workers in 5 bakeries was done in 2012, appr. 10 years after a similar study in 1999-2002. In addition a cross-sectional study in 2 other bakeries (one 'bread-factory', and a traditional bakery with three small bake shops) was added.
Altogether 253 participants, among them 61 former bakery workers, were investigated with use of questionnaires, allergy-testing (skin prick testing, and blood samples for specific IgE and total IgE), spirometry with reversibility testing, exhaled NO-measurement, and nasal measurements.
As in 1999-2002 an extensive exposure assessment was performed including personal samples of total dust (Gelman), inhalable dust (PAS6), as well as direct reading measurements of dust (Dust Track). A Job Exposure Matrix (JEM) was created enabling each participant to be assigned an exposure value of probable mean daily flour-dust exposure based on work-tasks and bakery.
Aim of study:
- Follow-up of the participants in the 1999-2002 study, both still active bakery workers and former workers, on health-status focusing on respiratory disease, sensitization to common and occupational allergens, level of sick-leave and reasons for quitting as a baker.
- Inclusion of 'new' bakery workers into the cohort as a cross-sectional study, and to compare health-status in two cross-sectional cohorts.
- To assess personal exposure to flour-dust among workers in 7 bakeries, as part of the cross-sectional study described above.
- To identify implemented flour-dust exposure reduction measures in bakeries participating in 1999-2002, and to assess the potential impact of these measures on the exposure to flour dust.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602237
|Dept. of Occupational Medicine, Haukeland University Hospital|
|Bergen, Norway, 5021|
|Principal Investigator:||Torgeir Storaas, PhD, MD||Haukeland University Hospital|
|Study Director:||Tor B Aasen, MD||Haukeland University Hospital|