Preventing Respiratory Health Problems in Bakery Employees

Rhinitis Clinical Trial

— Baker2012  

Official title:

Preventing Respiratory Health Problems in Bakery Employees.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602237
• Other study ID #: 2011/2449
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: August 11, 2017
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Employed in a bakery for more than 6 months

• and/or participant of the investigations done in 1999-2002 in 6 bakeries

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Rhinitis

Locations

Country	Name	City	State
Norway	Dept. of Occupational Medicine, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Kirkeleit J, Hollund BE, Riise T, Eduard W, Bråtveit M, Storaas T. Bakers' exposure to flour dust. J Occup Environ Hyg. 2017 Feb;14(2):81-91. — View Citation

Storaas T, Ardal L, Van Do T, Florvaag E, Steinsvåg 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. — View Citation

Storaas T, Irgens A, Florvaag E, Steinsvåg 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. — View Citation

Storaas T, Steinsvåg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Exhaled Volume in one second (FEV1)	The decline in FEV1 from 1999-2002 to 2012.	Change/decline from 1999-2002 to 2012
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

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