Range of Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Otherwise Healthy Smokers

Healthy Smokers Clinical Trial

Official title:

Range of Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Otherwise Healthy Smokers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00753870
• Other study ID #: 07-2060 (GCRC 2670)
• Secondary ID: P50HL084934-01
• Status: Terminated
• Phase: Phase 1
• First received: September 15, 2008
• Last updated: April 14, 2011
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Smokers

Intervention

Biological:
• CCRE inhalation
20,000 EU CCRE given as a one-time challenge

Locations

Country	Name	City	State
United States	UNC Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify a dose of inhaled CCRE that is well tolerated and that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.		post exposure	Yes

External Links

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