Chronic Obstructive Pulmonary Disease Clinical Trial
To characterize the nature of pulmonary responses to organic dust exposures in order to gain insight into patterns of respiratory disease in agricultural workers.
BACKGROUND:
In 1986 when the study began, agriculture was one of the largest employers in the United
States, comprising nearly 12 million people. Farm workers were hospitalized more frequently
than other occupational groups and were found to have the highest number of restricted
activity days due to injury and illness. Much of this was due to frequent and disabling farm
related accidents which made agriculture the most hazardous occupation in the United States.
Agricultural workers were also found to have high rates of respiratory disability, compared
with other industrial sectors, based on Social Security disability records.
The common denominator for respiratory disorders among agricultural workers was exposure to
organic dust which was recognized to be a complex mixture of vegetable particles and
fragments, microorganisms and their products, insects and insect fragments, feed additives
including fish meal and antibiotics, and avian and rodent proteins. While the vegetable dust
itself was by far the most important exposure, individual circumstances of growing, storage
and subsequent use of the product from which the organic dust arose, influenced specific
exposures. In certain situations, like animal confinement housing, irritant gases including
ammonia and hydrogen sulfide co-existed with an organic dust to further vary respiratory
exposure.
Workers exposed in Iowa swine production units were known to be significantly exposed to
grain dust, endotoxin, animal danders and other proteins, ammonia and hydrogen sulfide gas,
and a variety of microorganisms including fungi and thermophilic actinomycetes.
Cross-sectional epidemiological surveys had documented a high prevalence of respiratory
symptoms including chronic cough, phlegm and wheezing, but also prominent constitutional
symptoms including fever, myalgias and malaise. This study was one of several projects
supported by a Specialized Center of Research in Occupational and Immunologic Lung Disease.
Funding represents approximately 35 percent of the dollars of the Specialized Center of
Research in Occupational and Immunologic Lung Disease (P50HL37121) used to support
epidemiologic studies.
DESIGN NARRATIVE:
A nested case-control study was carried out on a previously studied cohort. Members of the
cohort were resurveyed in the first year of the study. All participants received a routine
physical examination, chest x-ray, electrocardiogram if over 40 years of age, routine
laboratory tests, methacholine challenge, intradermal skin testing, and bronchoalveolar
lavage. Cases for the swine confinement farmer cohort were selected if they had FEF50 of 60
percent or less of predicted for age, sex, height, and race. Three referents for each case
were randomly selected from all swine confinement farmers not selected as cases,
non-confinement farmers, and blue collar workers. Measurements were repeated in the fourth
year, finishing in the fifth year of the study. The study determined: the extent to which
epidemiological studies underestimated pulmonary responses and impairments among
agricultural workers; the environmental risk factors significantly related to cases; whether
atopy and heightened airway reactivity were significantly associated risk factors. The
subproject was not renewed in 1992.
The study completion date listed in this record was obtained from the "End Date" entered in
the old format Protocol Registration and Results System (PRS).
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