NCT01096537

Brief Summary

Background: Occupational exposures are thought to be responsible for 10-15% of new-onset asthma cases in adults, with disparities across sectors. Because most of the data are derived from registries and cross-sectional studies, little is known about incidence of occupational asthma (OA) during the first years after inception of exposure. This study focuses on this early asthma onset period among young workers in the bakery, pastry making and hairdressing sectors in order to assess early incidence of OA in these "at risk" occupations according to exposure duration, and to identify risk factors of OA. Methods: This study is a longitudinal retrospective study with a nested case-control to identify risk factors of OA. The assessment of incidence evolution is made by exploring a series of promotions (or retrospective cohorts) with increasing duration since at work. The study population is composed of subjects who graduated between 2001 and 2006 in sectors where they experience exposure to organic or inorganic allergenic or irritant compounds (with an objective of 150 subjects by year) and 250 young workers with no specific occupational exposure. This study is a descriptive, monocentric, longitudinal and retrospective study with cross-sectional measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
866

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 6, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

March 10, 2010

Last Update Submit

July 4, 2016

Conditions

Keywords

incidenceyoung workersoccupations at riskpublic healthepidemiologypolymorphismsgentic

Outcome Measures

Primary Outcomes (1)

  • The early incidence of OA among young workers according to their sector of activity and exposure duration.

    3-6 months after tle last inclusion

Secondary Outcomes (1)

  • The identification of risk factors of OA.

    3-6 months after the last inclusion

Study Arms (1)

Young workers

Exposed young workers graduated in sectors at risk of occupational asthma (bakery, pastry-making or hairdressing) "Non-exposed" young workers graduated in sectors without specific occupational exposure as the sale or the food sectors.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All bakers, pastry-makers and hairdressers who graduated between 2001 and 2006 from nine vocational schools in Lorraine, North-Eastern France, and all subjects who graduated in 2001 in the sale or the food sectors (butcher, pork butcher, caterer, cook job,…) from the same vocational schools.

You may qualify if:

  • for the exposed group: to be graduated between 2001 and 2006 from nine vocational schools in Lorraine, North-Eastern France
  • for the "non-exposed" group: to be graduated in 2001 in the sale or the food sectors (butcher, pork butcher, caterer, cook job,…) from the same vocational schools

You may not qualify if:

  • asthma diagnosed before apprenticeship
  • for the "non-exposed" group: to have worked previously or later in a sector at risk with OA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy

Nancy, 54000, France

Location

Related Publications (1)

  • Remen T, Coevoet V, Acouetey DS, Gueant JL, Gueant-Rodriguez RM, Paris C, Zmirou-Navier D. Early incidence of occupational asthma among young bakers, pastry-makers and hairdressers: design of a retrospective cohort study. BMC Public Health. 2010 Apr 26;10:206. doi: 10.1186/1471-2458-10-206.

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Asthma, Occupational

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOccupational Diseases

Study Officials

  • Christophe PARIS, MD / PhD

    CHU Nancy, INSERM, Nancy University

    PRINCIPAL INVESTIGATOR
  • Denis ZMIROU-NAVIER, MD / PhD

    INSERM, Nancy university, EHESP School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 31, 2010

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

July 6, 2016

Record last verified: 2016-03

Locations