Chronic Obstructive Pulmonary Disease Clinical Trial
The overall objective of the Center was to develop a scientific data base for the control
and prevention of acute and chronic lung injury caused by the inhalation of a variety of
agents in the workplace and in the environment. There were two epidemiologic studies.
Respiratory Effects of Exposures to Irritant Gases: To collect longitudinal lung function
and symptom data in chemical manufacturing workers who were exposed to chemical irritants
such as ammonia, chlorine, phosgene, isocyanates, sulphur dioxide, nitrous oxide,
formaldehyde, organic acids, hydrochloric acid fluorides, other aldehydes, and acid
anhydrides.
Workers in the Cotton Textile Industry: To detect and quantitate the risk for the
development of chronic obstructive airways disease which occurred in workers exposed to
cotton dust in textile manufacturing.
BACKGROUND:
The two projects were part of a Specialized Center of Research (SCOR) in Occupational and
Immunologic Lung Disease. Since its inception in 1972, researchers in the SCOR have
conducted epidemiologic studies on asbestosis, silicosis in sandblasters, and respiratory
reactions in workers exposed to detergent enzymes and polyvinyl chloride film fumes.
Irritant gases and vapors are utilized in herbicides, pesticides, pharmaceuticals, household
cleaners, explosives, fertilizers, refrigeration, plastics, paints, fumigants and a variety
of other products. These chemicals are produced and used immediately or shipped to
end-users. The potential for chemical accidents is great. A report for the Environmental
Protection Agency estimated that 6,928 chemical accidents have occurred in the United States
since 1980, an average of five accidents each day. As a result, 1,500 people were injured
and 135 killed. More information was needed on the consequences of chemically-induced
sublethal acute lung injury and on the long term outcome of chemical vapor/gas specific
injury in order to differentially treat exposure to these chemicals.
Byssinosis has been recognized as a respiratory disorder associated with cotton dust
exposure for more than two centuries. This respiratory disorder is characterized by the
clinical symptoms of bronchoconstriction with work week periodicity and later by a decline
in lung function over the working shift, most marked following an absence from the job.
Byssinosis risk is probably influenced by length of exposure and type of mill such as
textile mill, cottonseed oil crushing mill, or ginning mill. Prevalence seems not to be
influenced by age, sex, or race. This study attempted to answer the question whether
long-term exposure to cotton textile dust led to clinically important pulmonary functional
impairment.
DESIGN NARRATIVE:
Respiratory Effects of Exposures to Irritant Gases and Vapors:
Workers filled out respiratory questionnaires and underwent spirometry tests at their plants
at baseline with follow-up every one to two years over a five-year period. Initial total IgE
was measured in a 20 percent sample to determine its ability to detect longitudinal changes
in lung function and whether it mediated immunoreactivity. In workers exposed to chemical
spills, a determination was made if short-term, high level chemical exposure without lung
injury or short-term, high level chemical exposure with lung injury affects lung function
longitudinally or affects the acquisition of respiratory symptoms. In injured workers and a
matched control group, spirometry was performed immediately, at two weeks, at six weeks, and
at one year after the episode. In the week after an acute injury, circulating biochemical
indications of cell and tissue injury were measured. Total and specified IgE were measured
after injury and compared to baseline measurements.
The longitudinal study had two components. In the first, the Tulane SCOR investigators
collected pulmonary function, respiratory health, immunologic, and industrial hygiene data
on 300 workers in nine textile plants (six cotton and three synthetic) for comparison with
the company's data. In the second component, Tulane investigators worked closely with the
participating company to insure the quality of data the company collected in their
respiratory health surveillance program on workers in the nine plants.
Data were collected on sex, race, smoking, age, atopic status, degree of bronchoconstriction
in response to cotton dust exposure as measured by Monday shift change in FEV1, length of
employment, past and current exposure to cotton dust, job type, grade of cotton processed,
geographical location of the plant, and bacterial contamination of the cotton. Lung function
tests were conducted annually for five years by obtaining pre- and post-shift spirometric
data. Data were available on the company's dust measurements for the past ten years. Dust
measurements were made during the study to reconstruct a complete exposure profile for the
various job titles in each production area during the total period of employment of workers
participating in the study.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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