Preventing Respiratory Health Problems in Bakery Employees (Baker2012)
|ClinicalTrials.gov Identifier: NCT01602237|
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : August 14, 2017
|Condition or disease|
|Chronic Obstructive Lung Disease Rhinitis|
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.
|Study Type :||Observational|
|Actual Enrollment :||253 participants|
|Official Title:||Preventing Respiratory Health Problems in Bakery Employees.|
|Actual Study Start Date :||February 2012|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2015|
- Forced Exhaled Volume in one second (FEV1) [ Time Frame: Change/decline from 1999-2002 to 2012 ]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. ]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. ]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. ]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. ]Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|