Bronchial Obstruction in Dairy Farmers

COPD Clinical Trial

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Official title:

Bronchial Obstruction in Dairy Farmers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654469
• Other study ID #: 35RC11_8953
• Secondary ID: 2011-A01010-41
• Status: Completed
• Start date: February 27, 2012
• Est. completion date: December 2019

Study information

• Verified date: March 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1247
• Est. completion date: December 2019
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• questionnaires and electronic mini-spirometry
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

Locations

Country	Name	City	State
France	Rennes University Hospital - Service de Pneumologie	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of occupational specific COPD in dairy farmers	Occupational specific COPD is defined as a ratio FEV1 / FVC < 0.8 associated to a clinical situation : non reversibility after ß2-agonists or corticoids administration,; no personal nor familial allergic conditions,; smoking history < 1 cigarettes package per year.	3 years