Work Related AsthmaARPEIGENCT02879838
Occupational Respiratory Allergies and Gene-environment Interactions
An observational study of Work Related Asthma, run by Central Hospital, Nancy, France at 12 sites in France.
Trial summary
The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma. Secondary purposes are: to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration; to… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Work Related Asthma
- What is being tested?
- Blood sample
- How many people
- 400 participants
- Where
- 12 sitesFrance
- Study dates
- Sep 2016to Sep 2020
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men or women, professionally active, consulting in one of hospitals participating to the study for suspicion of work-related asthma .
Who may be able to join
- Patient consulting for suspected work-related asthma in one of hospitals participating to the study
Who cannot join
- Patient refusing to participate
- Pregnant or breastfeeding women
- Individual in life-threatening emergency
- Hospitalized patient
- Patient in a health or social institution
- Person deprived of liberty
Show all 10Show fewer
- Person with total occupational disability
- Retired person
- Person diagnosed as non-asthmatic
- Asthmatic person already enrolled in a clinical trial of bio-therapy to treat asthma
Trial locations and contacts
12 sites in 1 country.
Christophe Paris contact
12 sites in 1 country
France12 sites
Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux
Bordeaux
Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen
Caen
Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil
Créteil
Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble
Grenoble
Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes
Nantes
Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin
Paris
Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal
Paris
Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud
Pierre-Bénite
Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg
Strasbourg
Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg
Strasbourg
Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse
Toulouse
Centre de consultation de pathologies professionnelles, CHRU Nancy
Vandœuvre-lès-Nancy
About this study
The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.
Secondary purposes are:
- to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
- to estimate medical-social becoming of diagnosed work-related asthma after one year;
- to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.
Read the detailed description
Participants with work related asthma or suspected work related asthma will obtain a precise diagnosis concerning severity and control of respiratory disorder and also the possible effect of professional environment on the disorder. Their medical care and medico-legal care, in case of recognition of occupational disease, could be ameliorated.
In general, this study will allow the harmonization of diagnostic care and medical, medico-professional and medico-legal management of cases of work related asthma in specialized hospitals.
- Conditions
- Work Related Asthma
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Biobank. Analysis of cytokines and DNA polymorphisms
| Study group | Role | What they receive |
|---|---|---|
| Occupational Asthma | Not described Receives: Other: Blood sample | |
| Work Aggravated Asthma | Not described Receives: Other: Blood sample | |
| Non-Work-Related Asthma | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma
Interpretation of diagnostic algorithm of study
Measured: Inclusion
Secondary outcomes (6)
Nitric oxide level
Bronchial inflammation marker
Measured: Inclusion
Cytology of induced expectoration
Bronchial inflammation marker
Measured: Inclusion
Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test
Measured: Inclusion
Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow
Measured: Inclusion
Severity of symptoms
Measured: Inclusion
Costs of different types of asthma
Direct and induced costs
Measured: Inclusion and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Related 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Paris, Principal investigator, Centre de Consultation de Pathologies Professionnelles, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879838
- Sponsor's protocol ID
- ANSES-2013/ARPEIGE-PENVEN/MS
- Acronym
- ARPEIGE
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Respiratory Allergies and Gene-environment Interactions
- ClinicalTrials.gov ID
- NCT02879838
- Acronym / sponsor ID
- ARPEIGE / ANSES-2013/ARPEIGE-PENVEN/MS
- Conditions
- Work Related Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 26 Aug 2016 (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.
The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.
Secondary purposes are:
- to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
- to estimate medical-social becoming of diagnosed work-related asthma after one year;
- to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.
Detailed description
Participants with work related asthma or suspected work related asthma will obtain a precise diagnosis concerning severity and control of respiratory disorder and also the possible effect of professional environment on the disorder. Their medical care and medico-legal care, in case of recognition of occupational disease, could be ameliorated.
In general, this study will allow the harmonization of diagnostic care and medical, medico-professional and medico-legal management of cases of work related asthma in specialized hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Occupational Asthma | – | Other: Blood sample |
| Work Aggravated Asthma | – | Other: Blood sample |
| Non-Work-Related Asthma | – | Other: Blood sample |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men or women, professionally active, consulting in one of hospitals participating to the study for suspicion of work-related asthma .
Key inclusion criteria (1 listed)
- Patient consulting for suspected work-related asthma in one of hospitals participating to the study
Key exclusion criteria (10 listed)
- Patient refusing to participate
- Pregnant or breastfeeding women
- Individual in life-threatening emergency
- Hospitalized patient
- Patient in a health or social institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBiobank. Analysis of cytokines and DNA polymorphisms | Other | Non-Work-Related Asthma, Occupational Asthma, Work Aggravated Asthma |
Primary outcome
Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma
Time frame: Inclusion
Interpretation of diagnostic algorithm of study
6 secondary outcomes
Nitric oxide level
Time frame: Inclusion
Cytology of induced expectoration
Time frame: Inclusion
Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test
Time frame: Inclusion
Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow
Time frame: Inclusion
Severity of symptoms
Time frame: Inclusion
Costs of different types of asthma
Time frame: Inclusion and after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
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 contact
Christophe Paris principal investigator
Centre de Consultation de Pathologies Professionnelles, CHRU Nancy
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work Related Asthma, run by Central Hospital, Nancy, France at 12 sites 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Paris (c.paris@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2016; AzTrials last refreshed its copy on 1 Nov 2026.