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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00027235
Other study ID # NCRR-M01RR00036-0829
Secondary ID
Status Completed
Phase N/A
First received November 28, 2001
Last updated June 23, 2005

Study information

Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Locations

Country Name City State
United States Washington University, Division of Pulmonary and Critical Care Medicine St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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