Bronchial Obstruction in Dairy Farmers (BPCO Airbag)

March 28, 2023 updated by: Rennes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 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.

The dairy farmers had an occupational medicine appointment and, if they demonstrated at least one marker of possible bronchial obstruction (chronic cough, chronic bronchitis, dyspnoea, wheezing, spirometry), they were referred to a pulmonologist.

Study Type

Observational

Enrollment (Actual)

1247

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Rennes University Hospital - Service de Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of bronchial obstruction
Time Frame: 3 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of occupational specific COPD in dairy farmers
Time Frame: 3 years

Occupational specific COPD is defined as a ratio FEV1 / FVC < 0.8 associated to a clinical situation :

  • non reversibility after β2-agonists or corticoids administration,
  • no personal nor familial allergic conditions,
  • smoking history < 1 cigarettes package per year.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2012

Primary Completion (Actual)

February 15, 2017

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC11_8953
  • 2011-A01010-41 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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