Occupational Respiratory Allergies and Gene-environment Interactions

• Conditions: Work Related Asthma
• Interventions: Other: Blood sample

• Registration Number: NCT02879838
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26
• Study Start: 2016-09
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Occupational Asthma	Blood sample	-
Work Aggravated Asthma	Blood sample	-
Non-Work-Related Asthma	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma	Inclusion	Interpretation of diagnostic algorithm of study

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes; 🇫🇷 Nantes, France

Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite, France

Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin; 🇫🇷 Paris, France

Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen; 🇫🇷 Caen, France

Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse; 🇫🇷 Toulouse, France

Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux; 🇫🇷 Bordeaux, 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, Hôpital Fernand-Widal; 🇫🇷 Paris, 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, CHRU Nancy; 🇫🇷 Vandoeuvre les Nancy, France