Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Occupational Respiratory Allergies and Gene-environment Interactions (ARPEIGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02879838
Recruitment Status : Not yet recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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 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.

Condition or disease Intervention/treatment
Work Related Asthma Other: Blood sample

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Occupational Respiratory Allergies and Gene-environment Interactions
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Nitric oxide level [ Time Frame: Inclusion ]
    Bronchial inflammation marker

  2. Cytology of induced expectoration [ Time Frame: Inclusion ]
    Bronchial inflammation marker

  3. Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test [ Time Frame: Inclusion ]
  4. Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow [ Time Frame: Inclusion ]
  5. Severity of symptoms [ Time Frame: Inclusion ]
  6. Costs of different types of asthma [ Time Frame: Inclusion and after 1 year ]
    Direct and induced costs


Biospecimen Retention:   Samples With DNA
Blood sample for collection of human biological material for genotyping analysis


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879838


Contacts
Layout table for location contacts
Contact: Christophe Paris c.paris@chru-nancy.fr

Locations
Layout table for location information
France
Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, France
Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen
Caen, France
Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil
Créteil, France
Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble
Grenoble, France
Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes
Nantes, France
Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin
Paris, France
Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal
Paris, France
Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud
Pierre-Bénite, 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
Strasbourg, France
Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse
Toulouse, France
Centre de consultation de pathologies professionnelles, CHRU Nancy
Vandoeuvre les Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Principal Investigator: Christophe Paris Centre de Consultation de Pathologies Professionnelles, CHRU Nancy

Layout table for additonal information
Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02879838    
Other Study ID Numbers: ANSES-2013/ARPEIGE-PENVEN/MS
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Immune System Diseases