Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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