Lung Diseases, ObstructiveNCT00005288
Epidemiology and Pulmonary Response To Organic Dust Exposure
An observational study of Lung Diseases, Obstructive and Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1986to Nov 1991
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To characterize the nature of pulmonary responses to organic dust exposures in order to gain insight into patterns of respiratory disease in agricultural workers.
Read the 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).
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startDec 1986
- Study completionNov 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, ObstructiveStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005288
- Sponsor's protocol ID
- 2009
- Status last verified
- Apr 2001
- First submitted
- 25 May 2000
- Last updated
- 16 Jan 2017
- Results posted
- No
Publications
Merchant JA: Agricultural Respiratory Disease, In: Seminars in Respiratory Medicine - Vol. 7, Number 3. Thieme Inc, pp 211-224, New York, 1986
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
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.
PubMed 3830113Merchant JA. Preparing for disaster. Am J Public Health. 1986 Mar;76(3):233-5. doi: 10.2105/ajph.76.3.233. No abstract available.
PubMed 3946707Merchant 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
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
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
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
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
Merchant JA. New dimensions in occupational medicine. Iowa Med. 1987 Apr;77(4):177-9. No abstract available.
PubMed 3583660Merchant JA. Agricultural exposures to organic dusts. Occup Med. 1987 Apr-Jun;2(2):409-25.
PubMed 3303387Muldoon 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.
PubMed 3605466Merchant 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
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
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Pulmonary Response To Organic Dust Exposure
- ClinicalTrials.gov ID
- NCT00005288
- Acronym / sponsor ID
- 2009
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1986
- Study completion
- Nov 1991 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- BackgroundMerchant JA: Agricultural Respiratory Disease, In: Seminars in Respiratory Medicine - Vol. 7, Number 3. Thieme Inc, pp 211-224, New York, 1986
- BackgroundMerchant 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
- Background: PubMed 3830113Omenn 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.
- Background: PubMed 3946707Merchant JA. Preparing for disaster. Am J Public Health. 1986 Mar;76(3):233-5. doi: 10.2105/ajph.76.3.233. No abstract available.
- BackgroundMerchant 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
- BackgroundMerchant 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
- BackgroundDement 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
- BackgroundMerchant 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
- BackgroundMerchant 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
- Background: PubMed 3583660Merchant JA. New dimensions in occupational medicine. Iowa Med. 1987 Apr;77(4):177-9. No abstract available.
- Background: PubMed 3303387Merchant JA. Agricultural exposures to organic dusts. Occup Med. 1987 Apr-Jun;2(2):409-25.
- Background: PubMed 3605466Muldoon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Obstructive and Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005288, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.