Early Incidence of Occupational Asthma Among Bakers, Pastry-makers and Hairdressers (ABCD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Nancy
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01096537
First received: March 10, 2010
Last updated: December 27, 2010
Last verified: March 2010
  Purpose

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.


Condition
Occupational Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evolution of the Incidence of Occupational Asthma at the Beginning of the Activity of Young Bakers, Pastry-makers and Hairdressers, and Exploration of Its Risk Factors

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • The early incidence of OA among young workers according to their sector of activity and exposure duration. [ Time Frame: 3-6 months after tle last inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The identification of risk factors of OA. [ Time Frame: 3-6 months after the last inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum, plasma


Estimated Enrollment: 1150
Study Start Date: December 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • asthma diagnosed before apprenticeship
  • for the "non-exposed" group: to have worked previously or later in a sector at risk with OA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096537

Contacts
Contact: Thomas REMEN, PhD Student thomas.remen@nancy.inserm.fr
Contact: Christophe PARIS, MD/PhD Christophe.Paris@nancy.inserm.fr

Locations
France
CHU Nancy Recruiting
Nancy, France, 54000
Contact: Thomas REMEN, MSc       thomas.remen@nancy.inserm.fr   
Contact: Christophe PARIS, MD / PhD       Christophe.Paris@nancy.inserm.fr   
Principal Investigator: Christophe PARIS, MD / PhD         
Principal Investigator: Denis ZMIROU-NAVIER, MD / PhD         
Sub-Investigator: Stéphanie DOVI-ACOUETEY, MSc         
Sub-Investigator: Thomas REMEN, MSc         
Sponsors and Collaborators
Central Hospital, Nancy, France
Institut National de la Santé Et de la Recherche Médicale, France
University of Nancy
Investigators
Principal Investigator: Christophe PARIS, MD / PhD CHU Nancy, INSERM, Nancy University
Principal Investigator: Denis ZMIROU-NAVIER, MD / PhD INSERM, Nancy university, EHESP School of Public Health
  More Information

No publications provided by Central Hospital, Nancy, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe PARIS MD/PhD, Central Hospital
ClinicalTrials.gov Identifier: NCT01096537     History of Changes
Other Study ID Numbers: 2008-A00622-53
Study First Received: March 10, 2010
Last Updated: December 27, 2010
Health Authority: France: French Data Protection Authority

Keywords provided by Central Hospital, Nancy, France:
incidence
young workers
occupations at risk
public health
epidemiology
polymorphisms
gentic

Additional relevant MeSH terms:
Asthma
Asthma, Occupational
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Occupational Diseases

ClinicalTrials.gov processed this record on August 21, 2014