Preventing Respiratory Health Problems in Bakery Employees

Completed

• Conditions: Rhinitis; Chronic Obstructive Lung Disease

• Registration Number: NCT01602237
• Lead Sponsor: Haukeland University Hospital

Brief 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Primary Completion: 2012-12
• Study Completion: 2015-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Forced Exhaled Volume in one second (FEV1)	Change/decline from 1999-2002 to 2012	The decline in FEV1 from 1999-2002 to 2012.

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	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	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)
Skin reaction to prick testing with allergen extracts	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)
Specific IgE	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

Trial Locations

Locations (1)

Dept. of Occupational Medicine, Haukeland University Hospital; 🇳🇴 Bergen, Norway