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

NCT ID: NCT00753870

Last Updated: 2011-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed 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.

Conditions

Healthy Smokers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

Otherwise healthy smokers

Group Type: EXPERIMENTAL

CCRE inhalation

Intervention Type: BIOLOGICAL

20,000 EU CCRE given as a one-time challenge

Interventions

CCRE inhalation

20,000 EU CCRE given as a one-time challenge

Intervention Type: BIOLOGICAL

Other Intervention Names

CCRE (LPS)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

UNC_Chapel Hill

Principal Investigators

David B Peden, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Countries

United States

References

Bennett WD, Alexis NE, Almond M, Herbst M, Zeman KL, Peden DB. Effect of inhaled endotoxin on mucociliary clearance and airway inflammation in mild smokers and nonsmokers. J Aerosol Med Pulm Drug Deliv. 2014 Dec;27(6):459-65. doi: 10.1089/jamp.2013.1089.

Reference Type: DERIVED

PMID: 24568613 (View on PubMed)

Related Links

http://www.med.unc.edu/cemalb/

Related Info

Other Identifiers

P50HL084934-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-2060 (GCRC 2670)

Identifier Type: -

Identifier Source: org_study_id