Occupational Respiratory Allergies and Gene-environment Interactions (ARPEIGE)

August 23, 2016 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux
      • Caen, France
        • Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen
      • Créteil, France
        • Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil
      • Grenoble, France
        • Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble
      • Nantes, France
        • Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes
      • Paris, France
        • Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin
      • Paris, France
        • Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal
      • Pierre-Bénite, France
        • Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud
      • Strasbourg, France
        • Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg
      • Strasbourg, France
        • Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg
      • Toulouse, France
        • Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse
      • Vandoeuvre les Nancy, France
        • Centre de consultation de pathologies professionnelles, CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men or women, professionally active, consulting in one of hospitals participating to the study for suspicion of work-related asthma .

Description

Inclusion Criteria:

- Patient consulting for suspected work-related asthma in one of hospitals participating to the study

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Occupational Asthma
Other: Blood sample
Biobank. Analysis of cytokines and DNA polymorphisms
Work Aggravated Asthma
Other: Blood sample
Biobank. Analysis of cytokines and DNA polymorphisms
Non-Work-Related Asthma
Other: Blood sample
Biobank. Analysis of cytokines and DNA polymorphisms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitric oxide level
Time Frame: Inclusion
Bronchial inflammation marker
Inclusion
Cytology of induced expectoration
Time Frame: Inclusion
Bronchial inflammation marker
Inclusion
Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test
Time Frame: Inclusion
Inclusion
Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow
Time Frame: Inclusion
Inclusion
Severity of symptoms
Time Frame: Inclusion
Inclusion
Costs of different types of asthma
Time Frame: Inclusion and after 1 year
Direct and induced costs
Inclusion and after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Christophe Paris, Centre de consultation de pathologies professionnelles, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANSES-2013/ARPEIGE-PENVEN/MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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