Range of Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Otherwise Healthy Smokers
Range of Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Otherwise Healthy Smokers
Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of
 different workplaces, and is even found in homes. The endotoxin used for this study is
 obtained from the National Institutes of Health, and is called "Clinical Center Reference
 Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of
 inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other
 problems), but causes changes in sputum cell samples that the scientists can measure. Phase 1
 research studies like this one are not intended to be a treatment, but are a scientific
 investigation. Eventually, with these types of studies we will be able to examine why some
 people are more sensitive to endotoxin. Scientists at other universities have found that
 while most people do not have a considerable lung response to endotoxin at doses as high as
 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study
 is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but
 does not cause symptoms in our study subjects. In our previous studies in our lab, using an
 endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma
 with no major problems, and we have used 10,000 EUs of CCRE in subjects who are current
 smokers without seeing any problems.
We are looking for people who currently smoke a minimum of a half a pack of cigarettes each
 day. You must not have any other health problems, be pregnant or nursing a baby, or actively
 trying to become pregnant or to father a child.
Inclusion Criteria:

 -  current smoker

 -  healthy

 Exclusion Criteria:

 -  no asthma

 -  no chronic health conditions

 -  no daily cough

 -  not pregnant or nursing a baby

 -  not actively trying to get pregnant or father a child