Detection and Characterization of COPD in Dairy Farmers

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— BALISTIC  

Official title:

COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540408
• Other study ID #: P-2011-119
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: February 5, 2016
• Start date: November 2011
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

A pilot study from the investigators group suggests that the prevalence of chronic obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) are largely unknown. Although immunization against organic dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.

This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in subjects without any occupational exposure (control arm) through a vast COPD detection program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and patients with COPD without any occupational exposure; (iv) identifying etiological factors of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy farmers with COPD and dairy farmers with normal pulmonary function tests); and (v) constituting a cohort of COPD patients and control subjects for further longitudinal studies.

Data from selected patients (either current or former smokers) with mild COPD and from matched controls will also be analyzed in an ancillary study which objectives are to compare exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.

Description:

2000 dairy workers and 2000 subjects without any occupational exposure, all aged 40 to 74 years, will take part to a COPD screening program (spirometry and bronchodilation test) between September 2011 and October 2014.

Subjects with COPD and healthy matched controls will attend a second visit. If needed, COPD subjects will be asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. All subjects will complete several questionnaires (quality of life, respiratory symptoms, smoking habits,…). A complete medical history will be collected, and a blood sample will be taken. Subjects thereafter will complete arterial stiffness measurement, exhaled nitric oxide and pulmonary function testing pre- and 30-min post-bronchodilator. A symptom-limited incremental cycle exercise test will be performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal.

Exposure to organic dusts will be quantified through analyze of electrostatic wipes left at subjects' homes for 10 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

• subject aged 40-74 years

• either dairy farmer or unexposed to any occupational risk factor for COPD

Exclusion Criteria:

• COPD in GOLD stage 4

• pregnancy

• treatment with systemic corticosteroids

• established diagnosis of asthma

• established diagnosis of bronchiectasis

• established diagnosis of allergic alveolitis

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Environmental Exposure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

Degano B, Bouhaddi M, Laplante JJ, Botebol M, Annesi-Maesano I, Marescaux A, Roux P, Thaon I, Wolf JP, Regnard J, Dalphin JC. [COPD in dairy farmers: screening, characterization and constitution of a cohort. The BALISTIC study]. Rev Mal Respir. 2012 Nov;29(9):1149-56. doi: 10.1016/j.rmr.2012.08.007. Epub 2012 Oct 15. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	comparison of dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls	the magnitude of their perceived breathing discomfort at rest, at the middle of warm up, every 2-minute during exercise, and at peak exercise is rated by pointing to the 10-point Borg scale	2-year	No
Other	comparison of exercise tolerance dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls		2-year	No
Other	comparison of ventilatory constraints on tidal volume expansion between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls	In the relationship between tidal volume (VT) and ventilation (V'E), there is an inflection point beyond which almost no further change in VT is possible despite a continued increase in V'E. This inflection in the VT response marks the point were dyspnoea sharply raises because of mechanical constraints on VT expansion. This inflection point is determined for each patient by analyzing individual Hey plot.	2-year	No
Other	cardiovascular risk in COPD patients either never-smokers or current/former smokers	comparison of pulse wave velocity between smoking and non-smoking COPD	3-year	No
Primary	prevalence of COPD in dairy farmers and in unexposed subjects		3-year	No
Secondary	comparison of smoking habits between dairy farmers with COPD and unexposed COPD		4-year	No
Secondary	comparison of dyspnoea between dairy farmers with COPD and unexposed COPD	, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity	4-year	No
Secondary	comparison of lung function between dairy farmers with COPD and unexposed COPD		4-year	No
Secondary	comparison of bronchial exhaled nitric oxide between dairy farmers with COPD and unexposed COPD		4-year	No
Secondary	comparison of systemic inflammation between dairy farmers with COPD and unexposed COPD		4-year	No
Secondary	comparison of arterial stiffness between dairy farmers with COPD and unexposed COPD		4-year	No
Secondary	comparison of exercise capacity between dairy farmers with COPD and unexposed COPD		4-year	No
Secondary	comparison of exposure to organic dusts between dairy farmers with and without COPD		3-year	No
Secondary	comparison of immunization to organic dusts between dairy farmers with and without COPD		3-year	No