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

Phase 1

Completed

• Conditions: Healthy; Cigarette Smoking
• Interventions: Biological: 20K EU CCRE

• Registration Number: NCT00924768
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-03
• Last Update Posted: 2013-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

• Any acute illness any chronic illness which would impact results

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endotoxin	20K EU CCRE	Inhalation of 20K EU CCRE

Primary Outcome Measures

Name	Time	Method
Increase in sputum neutrophils	6 hours

Secondary Outcome Measures

Name	Time	Method
Mucociliary clearance rates	4 hours

Trial Locations

Locations (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology; 🇺🇸 Chapel Hill, North Carolina, United States