Clinical trial NCT02879838: Occupational Respiratory Allergies and Gene-environment Interactions
Official title: Occupational Respiratory Allergies and Gene-environment Interactions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Work Related Asthma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 .

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.

Eligibility 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

Primary outcomes:
measure: Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma
timeFrame: Inclusion
Secondary outcomes:
measure: Nitric oxide level
timeFrame: Inclusion
measure: Cytology of induced expectoration
timeFrame: Inclusion
measure: Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test
timeFrame: Inclusion
measure: Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow
timeFrame: Inclusion
measure: Severity of symptoms
timeFrame: Inclusion
measure: Costs of different types of asthma
timeFrame: Inclusion and after 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux
city: Caen
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen
city: Créteil
country: France
facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil
city: Grenoble
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble
city: Nantes
country: France
facility: Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes
city: Paris
country: France
facility: Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin
city: Paris
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal
city: Pierre-Bénite
country: France
facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud
city: Strasbourg
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg
city: Strasbourg
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg
city: Toulouse
country: France
facility: Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse
city: Vandoeuvre les Nancy
country: France
facility: Centre de consultation de pathologies professionnelles, CHRU Nancy
Study officials:
affiliation: Centre de Consultation de Pathologies Professionnelles, CHRU Nancy
name: Christophe Paris
role: PRINCIPAL_INVESTIGATOR
References: