Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-26 @ 4:49 PM
Study NCT ID:
NCT00027235
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Popcorn Lung: the Discovery of a New Disease
Sponsor:
National Center for Research Resources (NCRR)
Organization:
Study Overview
Official Title:
Popcorn Lung: the Discovery of a New Disease
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: