NCT03654469

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem and is expected to become the 3rd leading cause of death globally by 2020. The main risk factor is tobacco. Tobacco poisoning is found in 80 to 90% of patients with COPD. However, non-smoking COPD is also described, with increasing prevalence figures, particularly related to occupational exposure, especially among farmers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 27, 2012

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

September 13, 2016

Last Update Submit

March 28, 2023

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Level of bronchial obstruction

    Respiratory specific indices are extracted from a screening spirometry : Forced expiratory volume in one second (FEV1) Forced Vital Capacity (FVC) Bronchial obstruction is stated with a ratio FEV1 / FVC \< 0.8

    3 years

Secondary Outcomes (1)

  • Prevalence of occupational specific COPD in dairy farmers

    3 years

Interventions

questionnaires and electronic mini-spirometryOTHER

prospective screening study based on questionnaires and electronic mini-spirometry (Néo-6(®)) that includes a representative sample of dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany * control: non farmer

You may qualify if:

  • dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
  • control: non farmer

You may not qualify if:

  • pigs or grain farmers
  • Pregnant women
  • oral corticosteroids or immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital - Service de Pneumologie

Rennes, 35033, France

Location

Related Publications (1)

  • Jouneau S, Chapron A, Ropars C, Marette S, Robert AM, Gouyet T, Belleguic C, Rochefort-Morel C, Guillot S, Mailloux C, Desrues B, Viel JF; AIRBAg research group. Prevalence and risk factors of asthma in dairy farmers: Ancillary analysis of AIRBAg. Environ Res. 2022 Nov;214(Pt 4):114145. doi: 10.1016/j.envres.2022.114145. Epub 2022 Aug 20.

    PMID: 35998695DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma of patients are collected

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stéphane Jouneau, MD, PhD

    Rennes University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

August 31, 2018

Study Start

February 27, 2012

Primary Completion

February 15, 2017

Study Completion

December 1, 2019

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

FR(1)