Epidemiology and Pulmonary Response To Organic Dust Exposure
Primary Purpose
Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Diseases, Obstructive
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005288
First Posted
May 25, 2000
Last Updated
January 13, 2017
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005288
Brief Title
Epidemiology and Pulmonary Response To Organic Dust Exposure
Study Type
Observational
2. Study Status
Record Verification Date
April 2001
Overall Recruitment Status
Completed
Study Start Date
December 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1991 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To characterize the nature of pulmonary responses to organic dust exposures in order to gain insight into patterns of respiratory disease in agricultural workers.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
Citation
Merchant JA: Agricultural Respiratory Disease, In: Seminars in Respiratory Medicine - Vol. 7, Number 3. Thieme Inc, pp 211-224, New York, 1986
Results Reference
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Citation
Merchant JA: Silicosis Issues - Past, Present, Future. Published in Book: Silica, Silicosis, and Cancer: Controversy in Occupational Medicine, 1986, Goldsmith DF, Winn DM, Shy CM (Eds), Praeger Special Studies, Praeger Scientific, pp 87-90, New York, 1986
Results Reference
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PubMed Identifier
3830113
Citation
Omenn GS, Merchant J, Boatman E, Dement JM, Kuschner M, Nicholson W, Peto J, Rosenstock L. Contribution of environmental fibers to respiratory cancer. Environ Health Perspect. 1986 Dec;70:51-6. doi: 10.1289/ehp.867051.
Results Reference
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PubMed Identifier
3946707
Citation
Merchant JA. Preparing for disaster. Am J Public Health. 1986 Mar;76(3):233-5. doi: 10.2105/ajph.76.3.233. No abstract available.
Results Reference
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Citation
Merchant JA: Contribution to Report The Health Consequences of Smoking: Cancer and Chronic Lung Disease in the Workplace: A Report of the Surgeon General. U.S. Department of Health and Human Services, Public Health Service, Office on Smoking and Health, U.S. Government Printing Service, Washington, D.C., 1986
Results Reference
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Citation
Merchant JA, Boehlecke BA, Taylor G (EDs): Occupational Respiratory Diseases, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, U.S. Government Printing Office, Washington, D.C., 1986
Results Reference
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Citation
Dement JM, Merchant JA: Chapter III. C: Asbestosis, in Occupational Respiratory Diseases, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, U.S. Government Printing Office, Washington, D.C., 1986
Results Reference
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Citation
Merchant JA: Chapter VI. Byssinosis, in Occupational Respiratory Diseases, U.S. Department of Health and Human Services, Public Health Services, Centers for Disease Control, National Institute for Occupational Safety and Health, U.S. Government Printing Office, Washington, D.C., 1986
Results Reference
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Citation
Merchant JA, Hodous T, Taylor G, Reger R: Chapter III. D: Coal Workers Pneumoconiosis, in Occupational Respiratory Diseases, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, U.S. Government Printing Office, Washington, D.C., 1986
Results Reference
background
PubMed Identifier
3583660
Citation
Merchant JA. New dimensions in occupational medicine. Iowa Med. 1987 Apr;77(4):177-9. No abstract available.
Results Reference
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PubMed Identifier
3303387
Citation
Merchant JA. Agricultural exposures to organic dusts. Occup Med. 1987 Apr-Jun;2(2):409-25.
Results Reference
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PubMed Identifier
3605466
Citation
Muldoon JT, Wintermeyer LA, Eure JA, Fuortes L, Merchant JA, Van Lier SF, Richards TB. Occupational disease surveillance data sources, 1985. Am J Public Health. 1987 Aug;77(8):1006-8. doi: 10.2105/ajph.77.8.1006.
Results Reference
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Citation
Merchant JA, Donham KJ: Health Risks from Animal Confinement Units. Proceedings of the International Symposium on Health and Safety in Agriculture. Saskatoon, Canada. In press, 1987
Results Reference
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Citation
Guernsey JR, Morgan DP, Marx JJ, Horvath EP, Pierce P, Merchant JA: The Prognostic Significance of Farmer's Lung Disease Antibodies Relative to Measures of Respiratory Disease. Proceedings of the International Symposium on Health and Safety in Agriculture, Saskatoon, Canada. In press, 1987
Results Reference
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Citation
Leistikow BN, Donham KJ, Merchant JA: Health Hazards of Poultry Production: Proceedings of the International Symposium on Health and Safety in Agriculture, Saskatoon, Canada. In press, 1987
Results Reference
background
PubMed Identifier
3383075
Citation
Twiggs JT, Gray RL, Marx JJ Jr. House dust mite (Dermatophagoides farinae) allergen levels in three different sources from homes of patients with allergy to house dust mite. Clin Rev Allergy. 1988 Spring;6(1):35-43. doi: 10.1007/BF02914980. No abstract available.
Results Reference
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Citation
Merchant JA: Occupational Parenchymal Lung Disease. Kelley: Textbook of Internal Medicine. In press, 1988
Results Reference
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PubMed Identifier
2455072
Citation
LaMarte FP, Merchant JA, Casale TB. Acute systemic reactions to carbonless copy paper associated with histamine release. JAMA. 1988 Jul 8;260(2):242-3.
Results Reference
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PubMed Identifier
2361895
Citation
Schwartz DA, Galvin JR, Dayton CS, Stanford W, Merchant JA, Hunninghake GW. Determinants of restrictive lung function in asbestos-induced pleural fibrosis. J Appl Physiol (1985). 1990 May;68(5):1932-7. doi: 10.1152/jappl.1990.68.5.1932.
Results Reference
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PubMed Identifier
2220828
Citation
Donham KJ, Merchant JA, Lassise D, Popendorf WJ, Burmeister LF. Preventing respiratory disease in swine confinement workers: intervention through applied epidemiology, education, and consultation. Am J Ind Med. 1990;18(3):241-61. doi: 10.1002/ajim.4700180303.
Results Reference
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Citation
Merchant JA, Donham KJ, Popendorf WJ, Burmeister LF, Lassise DG, Lee NF, Weinrich AJ: Acute Responses Among Swine Confinement Workers. Proceedings of Agricultural, Occupational, and Environmental Health: Health Policy Strategies for the Future. Iowa City, Iowa. In press 1988
Results Reference
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PubMed Identifier
1546862
Citation
Schwartz DA, Landas SK, Lassise DL, Burmeister LF, Hunninghake GW, Merchant JA. Airway injury in swine confinement workers. Ann Intern Med. 1992 Apr 15;116(8):630-5. doi: 10.7326/0003-4819-116-8-630.
Results Reference
background
PubMed Identifier
8430958
Citation
Marx JJ Jr, Twiggs JT, Ault BJ, Merchant JA, Fernandez-Caldas E. Inhaled aeroallergen and storage mite reactivity in a Wisconsin farmer nested case-control study. Am Rev Respir Dis. 1993 Feb;147(2):354-8. doi: 10.1164/ajrccm/147.2.354.
Results Reference
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Epidemiology and Pulmonary Response To Organic Dust Exposure
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