Lung Diseases, ObstructiveNCT00005280
Specialized Center of Research in Occupational and Immunologic Lung Disease
An observational study of Lung Diseases, Obstructive and Asbestosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Obstructive, Asbestosis, Silicosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1972to 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
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.
Read the detailed description
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.
- Conditions
- Lung Diseases, Obstructive, Asbestosis, Silicosis, Pneumoconiosis, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Lung Diseases, Obstructive, Asbestosis, Silicosis, Pneumoconiosis, 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 startJun 1972
- Study completionNov 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (240)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
- Investigators
- Hans Weill, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005280
- Sponsor's protocol ID
- 2001
- Other IDs
- P50HL015092
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Jones RN, Rando RJ, Glindmeyer HW, Foster TA, Hughes JM, O'Neil CE, Weill H. Abnormal lung function in polyurethane foam producers. Weak relationship to toluene diisocyanate exposures. Am Rev Respir Dis. 1992 Oct;146(4):871-7. doi: 10.1164/ajrccm/146.4.871.
PubMed 1329591Bozelka BE, Lehrer SB, Salvaggio JE, Hammad Y, McCants ML. Chronological assessment of asbestos exposure on cell composition in murine lung. Am J Med Sci. 1992 Jun;303(6):379-86. doi: 10.1097/00000441-199206000-00005.
PubMed 1605166Palmgren MS, deShazo RD, Carter RM, Zimny ML, Shah SV. Mechanisms of neutrophil damage to human alveolar extracellular matrix: the role of serine and metalloproteases. J Allergy Clin Immunol. 1992 Apr;89(4):905-15. doi: 10.1016/0091-6749(92)90447-a.
PubMed 1560171Cherniack RM, Colby TV, Flint A, Thurlbeck WM, Waldron J, Ackerson L, King TE Jr. Quantitative assessment of lung pathology in idiopathic pulmonary fibrosis. The BAL Cooperative Group Steering Committee. Am Rev Respir Dis. 1991 Oct;144(4):892-900. doi: 10.1164/ajrccm/144.4.892.
PubMed 1718192Glindmeyer HW, Lefante JJ, Jones RN, Rando RJ, Abdel Kader HM, Weill H. Exposure-related declines in the lung function of cotton textile workers. Relationship to current workplace standards. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):675-83. doi: 10.1164/ajrccm/144.3_Pt_1.675.
PubMed 1892310Bronchoalveolar lavage constituents in healthy individuals, idiopathic pulmonary fibrosis, and selected comparison groups. The BAL Cooperative Group Steering Committee. Am Rev Respir Dis. 1990 May;141(5 Pt 2):S169-202. doi: 10.1164/ajrccm/141.5_Pt_2.S169. No abstract available.
PubMed 2186681Lefante JJ. The power to detect differences in average rates of change in longitudinal studies. Stat Med. 1990 Apr;9(4):437-46. doi: 10.1002/sim.4780090414.
PubMed 2362980Weill H, Waggenspack C, Bailey W, Ziskind M, Rossiter C. Radiographic and physiologic patterns among workers engaged in manufacture of asbestos cement products: a preliminary report. J Occup Med. 1973 Mar;15(3):248-52. No abstract available.
PubMed 4348280Weill H, Waggenspack C, DeRouen T, Ziskind M. Respiratory reactions to B. subtilis enzymes in detergents. J Occup Med. 1973 Mar;15(3):267-71. No abstract available.
PubMed 4632631Weill H. Pulmonary function testing in industry. J Occup Med. 1973 Sep;15(9):693-9. No abstract available.
PubMed 4731662Allen GC, Samimi B, Ziskind M, Weill H. X-ray diffraction determination of alpha-quartz in respirable and total dust samples from sand-blasting operations. Am Ind Hyg Assoc J. 1974 Nov;35(11):711-7. doi: 10.1080/0002889748507091. No abstract available.
PubMed 4372876Bailey WC, Brown M, Buechner HA, Weill H, Ichinose H, Ziskind M. Silico-mycobacterial disease in sandblasters. Am Rev Respir Dis. 1974 Aug;110(2):115-25. doi: 10.1164/arrd.1974.110.2.115. No abstract available.
PubMed 4137927Glindmeyer H, Weill H, Jones R, Ziskind M. Design and operation of a mobile pulmonary function laboratory. J Occup Med. 1974 Sep;16(9):584-8. doi: 10.1097/00043764-197409000-00002. No abstract available.
PubMed 4851305Rossiter CE, Weill H. Ethnic differences in lung function: evidence for proportional differences. Int J Epidemiol. 1974 Mar;3(1):55-61. doi: 10.1093/ije/3.1.55. No abstract available.
PubMed 4838716Rossiter CE, Weill H. Synergism between dust exposure and smoking: an artefact in the statistical analysis of lung function. Bull Physiopathol Respir (Nancy). 1974 Sep-Oct;10(5):717-25. No abstract available.
PubMed 4441761
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Center of Research in Occupational and Immunologic Lung Disease
- ClinicalTrials.gov ID
- NCT00005280
- Acronym / sponsor ID
- 2001
- Conditions
- Lung Diseases, Obstructive, Asbestosis, Silicosis, Pneumoconiosis, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1972
- 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.
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.
Detailed description
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.
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 13 May 2016.
- Background: PubMed 1329591Jones RN, Rando RJ, Glindmeyer HW, Foster TA, Hughes JM, O'Neil CE, Weill H. Abnormal lung function in polyurethane foam producers. Weak relationship to toluene diisocyanate exposures. Am Rev Respir Dis. 1992 Oct;146(4):871-7. doi: 10.1164/ajrccm/146.4.871.
- Background: PubMed 1605166Bozelka BE, Lehrer SB, Salvaggio JE, Hammad Y, McCants ML. Chronological assessment of asbestos exposure on cell composition in murine lung. Am J Med Sci. 1992 Jun;303(6):379-86. doi: 10.1097/00000441-199206000-00005.
- Background: PubMed 1560171Palmgren MS, deShazo RD, Carter RM, Zimny ML, Shah SV. Mechanisms of neutrophil damage to human alveolar extracellular matrix: the role of serine and metalloproteases. J Allergy Clin Immunol. 1992 Apr;89(4):905-15. doi: 10.1016/0091-6749(92)90447-a.
- Background: PubMed 1718192Cherniack RM, Colby TV, Flint A, Thurlbeck WM, Waldron J, Ackerson L, King TE Jr. Quantitative assessment of lung pathology in idiopathic pulmonary fibrosis. The BAL Cooperative Group Steering Committee. Am Rev Respir Dis. 1991 Oct;144(4):892-900. doi: 10.1164/ajrccm/144.4.892.
- Background: PubMed 1892310Glindmeyer HW, Lefante JJ, Jones RN, Rando RJ, Abdel Kader HM, Weill H. Exposure-related declines in the lung function of cotton textile workers. Relationship to current workplace standards. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):675-83. doi: 10.1164/ajrccm/144.3_Pt_1.675.
- Background: PubMed 2186681Bronchoalveolar lavage constituents in healthy individuals, idiopathic pulmonary fibrosis, and selected comparison groups. The BAL Cooperative Group Steering Committee. Am Rev Respir Dis. 1990 May;141(5 Pt 2):S169-202. doi: 10.1164/ajrccm/141.5_Pt_2.S169. No abstract available.
- Background: PubMed 2362980Lefante JJ. The power to detect differences in average rates of change in longitudinal studies. Stat Med. 1990 Apr;9(4):437-46. doi: 10.1002/sim.4780090414.
- Background: PubMed 4348280Weill H, Waggenspack C, Bailey W, Ziskind M, Rossiter C. Radiographic and physiologic patterns among workers engaged in manufacture of asbestos cement products: a preliminary report. J Occup Med. 1973 Mar;15(3):248-52. No abstract available.
- Background: PubMed 4632631Weill H, Waggenspack C, DeRouen T, Ziskind M. Respiratory reactions to B. subtilis enzymes in detergents. J Occup Med. 1973 Mar;15(3):267-71. No abstract available.
- Background: PubMed 4731662Weill H. Pulmonary function testing in industry. J Occup Med. 1973 Sep;15(9):693-9. No abstract available.
- Background: PubMed 4372876Allen GC, Samimi B, Ziskind M, Weill H. X-ray diffraction determination of alpha-quartz in respirable and total dust samples from sand-blasting operations. Am Ind Hyg Assoc J. 1974 Nov;35(11):711-7. doi: 10.1080/0002889748507091. No abstract available.
- Background: PubMed 4137927Bailey WC, Brown M, Buechner HA, Weill H, Ichinose H, Ziskind M. Silico-mycobacterial disease in sandblasters. Am Rev Respir Dis. 1974 Aug;110(2):115-25. doi: 10.1164/arrd.1974.110.2.115. No abstract available.
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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.
Hans Weill
Tulane University
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Obstructive and Asbestosis, 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 13 May 2016. 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 NCT00005280, which also lists 240 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 13 May 2016.