- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027235
Popcorn Lung: the Discovery of a New Disease
June 23, 2005 updated by: National Center for Research Resources (NCRR)
Recently, an epidemic of pulmonary disease has been recognized among workers in a popcorn factory in Jasper, Missouri.
The exposure agent has not yet been identified, but suspects include butter flavoring and the powdered salt used in the mixing room.
This disease resembles "Bronchiolitis Obliterans Syndrome", an illness that makes it difficult to breathe.
Of the 117 workers studied, one year later, 25 subjects whom were working in the mixing room or in the microwave packaging area have had decreases in lung function seven times the norm for their age.
Industrial hygiene experts revealed that dust concentrations of salt and other flavorings were much higher in the mixing room compared to the office and outdoor work areas.
Recently, rats were exposed to vapors created by heating the butter flavor compound obtained from this plant.
Six-hour exposure to vapors at very high concentration resulted in significant damage to the breathing apparatus.
Thus, there is clinical, epidemiological, and animal toxicity data that appears to implicate some constituent present during the mixing of the butter flavoring, salt, and oil causing a form of obstructive airway disease that has been rapidly progressive in a number of workers.
It is not clear what the pathophysiologic nature of this entity is, though it resembles Bronchiolitis Obliterans Syndrome.
It is not known what the long term consequence of this will be on the active workers, nor is it clear whether preventive measures taken to reduce exposures in the mixing room and elsewhere in the plant are going to be effective.
Study Overview
Status
Completed
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University, Division of Pulmonary and Critical Care Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Current employees who have a decline in FEV1 larger than 200cc within the past year will be eligible to participate.
All index cases will be eligible to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 28, 2001
First Submitted That Met QC Criteria
November 28, 2001
First Posted (Estimate)
November 29, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCRR-M01RR00036-0829
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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