Preventing Respiratory Health Problems in Bakery Employees (Baker2012)

Preventing Respiratory Health Problems in Bakery Employees.

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis; Chronic Obstructive Lung Disease

Detailed Description

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
• Enrollment (Actual): 253

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Dept. of Occupational Medicine, Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. All the employees in 5 bakeries investigated in 1999-2002 (one of the original 6 bakeries has fused with one of the others)
2. All the employees in additional 2 bakeries located in the same Hordaland county, Norway, as the other 5 bakeries

Description

Inclusion Criteria:

• Employed in a bakery for more than 6 months
• and/or participant of the investigations done in 1999-2002 in 6 bakeries

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bakery workers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Exhaled Volume in one second (FEV1)	The decline in FEV1 from 1999-2002 to 2012.	Change/decline from 1999-2002 to 2012

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC)	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	Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Inflammation markers in nasal lavage	Measurement in nasal lavage of inflammation markers (albumin, tryptase, eosinophilic cationic protein) when at work (field study)	Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Specific IgE	In serum measurement of specific IgE to common airborne allergens, and allergens mainly found in bakeries	Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.
Skin reaction to prick testing with allergen extracts	Skin prick test with commercially available allergen extracts (common and occupational allergens in bakeries)	Each participant will be investigated once. Anticipated recruitment time for the whole cohort (study population I and II): about 10 months.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Torgeir Storaas, PhD, MD, Haukeland University Hospital; Study Director: Tor B Aasen, MD, Haukeland University Hospital

Publications and helpful links

General Publications

• Storaas T, Irgens A, Florvaag E, Steinsvag SK, Ardal L, Do TV, Greiff L, Aasen TB. Bronchial responsiveness in bakery workers: relation to airway symptoms, IgE sensitization, nasal indices of inflammation, flour dust exposure and smoking. Clin Physiol Funct Imaging. 2007 Sep;27(5):327-34. doi: 10.1111/j.1475-097X.2007.00755.x.
• Storaas T, Ardal L, Van Do T, Florvaag E, Steinsvag SK, Irgens A, Aasen TB, Greiff L. Nasal indices of eosinophilic and exudative inflammation in bakery-workers. Clin Physiol Funct Imaging. 2007 Jan;27(1):23-9. doi: 10.1111/j.1475-097X.2007.00707.x.
• Storaas T, Steinsvag SK, Florvaag E, Irgens A, Aasen TB. Occupational rhinitis: diagnostic criteria, relation to lower airway symptoms and IgE sensitization in bakery workers. Acta Otolaryngol. 2005 Nov;125(11):1211-7. doi: 10.1080/00016480510044205.
• Kirkeleit J, Hollund BE, Riise T, Eduard W, Bratveit M, Storaas T. Bakers' exposure to flour dust. J Occup Environ Hyg. 2017 Feb;14(2):81-91. doi: 10.1080/15459624.2016.1225156.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Rhinitis
• Other Study ID Numbers: 2011/2449