NCT02879838

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

August 23, 2016

Last Update Submit

August 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma

    Interpretation of diagnostic algorithm of study

    Inclusion

Secondary Outcomes (6)

  • Nitric oxide level

    Inclusion

  • Cytology of induced expectoration

    Inclusion

  • Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test

    Inclusion

  • Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow

    Inclusion

  • Severity of symptoms

    Inclusion

  • +1 more secondary outcomes

Study Arms (3)

Occupational Asthma

Other: Blood sample

Work Aggravated Asthma

Other: Blood sample

Non-Work-Related Asthma

Other: Blood sample

Interventions

Biobank. Analysis of cytokines and DNA polymorphisms

Non-Work-Related AsthmaOccupational AsthmaWork Aggravated Asthma

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux

Bordeaux, France

Location

Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen

Caen, France

Location

Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil

Créteil, France

Location

Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble

Grenoble, France

Location

Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes

Nantes, France

Location

Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin

Paris, France

Location

Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal

Paris, France

Location

Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Location

Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg

Strasbourg, France

Location

Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg

Strasbourg, France

Location

Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse

Toulouse, France

Location

Centre de consultation de pathologies professionnelles, CHRU Nancy

Vandœuvre-lès-Nancy, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for collection of human biological material for genotyping analysis

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christophe Paris

    Centre de Consultation de Pathologies Professionnelles, CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Paris

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations