Occupational AsthmaABCDNCT01096537
Early Incidence of Occupational Asthma Among Bakers, Pastry-makers and Hairdressers
An observational study of Occupational Asthma, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Occupational Asthma
- How many people
- 866 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- asthma diagnosed before apprenticeship
- for the "non-exposed" group: to have worked previously or later in a sector at risk with OA
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Occupational Asthma
- Keywords
- incidence, young workers, occupations at risk, public health, epidemiology, polymorphisms, gentic
- Medical subject headings
- Asthma, Occupational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The early incidence of OA among young workers according to their sector of activity and exposure duration.
Measured: 3-6 months after tle last inclusion
Secondary outcomes (1)
The identification of risk factors of OA.
Measured: 3-6 months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational AsthmaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Nancy
- Responsible party
- Sponsor
- Investigators
- Christophe PARIS, MD / PhD, Principal investigator, CHU Nancy, INSERM, Nancy UniversityDenis ZMIROU-NAVIER, MD / PhD, Principal investigator, INSERM, Nancy university, EHESP School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096537
- Sponsor's protocol ID
- 2008-A00622-53
- Acronym
- ABCD
- Status last verified
- Mar 2016
- First submitted
- 10 Mar 2010
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20420675
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01096537
- Acronym / sponsor ID
- ABCD / 2008-A00622-53
- Conditions
- Occupational Asthma
- Keywords
- incidence, young workers, occupations at risk, public health, epidemiology, polymorphisms, gentic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Nancy
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- asthma diagnosed before apprenticeship
- for the "non-exposed" group: to have worked previously or later in a sector at risk with OA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The identification of risk factors of OA.
Time frame: 3-6 months after the last inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Derived from this study: PubMed 20420675Remen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe PARIS, MD / PhD principal investigator
CHU Nancy, INSERM, Nancy University
Denis ZMIROU-NAVIER, MD / PhD principal investigator
INSERM, Nancy university, EHESP School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Asthma, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.