A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers

NCT ID: NCT00924768

Last Updated: 2013-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-06-30

Brief Summary

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. The investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.

Detailed Description

The purpose of this study is to determine the range of neutrophil response (influx of PMNs to the airways as determined in sputum) after inhalation of CCRE (20,000 EU), shown in previous studies of healthy, nonsmoking volunteers as well as in a limited number of otherwise healthy smokers to be well tolerated. This dose 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. Limitations of the understanding of actions of inflammatory stimuli on airway function are likely due to the fact that functional assessments of dynamic airway response /in vivo/ have generally been limited to those based on spirometry and examination of airway samples for assessment of cells and mediator content. Slowing of mucociliary clearance (MCC), a key component of airway defense, can be induced by inflammation and almost certainly contribute to mucus plugging and decreased clearance of inhaled irritants. Measures of mucociliary clearance (MCC), by inhalation of radiolabeled particles to label airway surface liquid, suggest that clearance of secretions is impaired to a mild degree in smokers and more severely in patients hospitalized for acute exacerbations.

Conditions

Healthy; Cigarette Smoking

Study Design

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

Study Groups

Endotoxin

Inhalation of 20K EU CCRE

Group Type: EXPERIMENTAL

20K EU CCRE

Intervention Type: BIOLOGICAL

Inhalation of CCRE

Interventions

20K EU CCRE

Inhalation of CCRE

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Must be current cigarette smokers
• Must be otherwise healthy
• Must be good sputum producers

Exclusion Criteria

• Any acute illness any chronic illness which would impact results

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

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

David B. Peden, MD

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Peden

Role: PRINCIPAL_INVESTIGATOR

University of NC Chapel Hill Hospitals

Locations

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

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

Related Info

Other Identifiers

NHLBI P50-HL084934

Identifier Type: -

Identifier Source: secondary_id

BB9998 Protocol 14

Identifier Type: -

Identifier Source: org_study_id