Back to resultsA Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers (IRB 09-0259)
Primary Purpose
Healthy, Cigarette Smoking
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
20K EU CCRE
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Otherwise healthy current cigarette smokers, current cigarette smokers
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
Sites / Locations
- UNC Center for Environmental Medicine, Asthma and Lung Biology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endotoxin
Arm Description
Inhalation of 20K EU CCRE
Outcomes
Primary Outcome Measures
Increase in sputum neutrophils
Secondary Outcome Measures
Mucociliary clearance rates
Full Information
NCT ID
NCT00924768
First Posted
June 17, 2009
Last Updated
August 3, 2013
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00924768
Brief Title
A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers
Acronym
IRB 09-0259
Official Title
A Study of Inhalation of 20,000 EU CCRE and MCC in Otherwise Healthy Individuals Who Are Current Cigarette Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Cigarette Smoking
Keywords
Otherwise healthy current cigarette smokers, current cigarette smokers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endotoxin
Arm Type
Experimental
Arm Description
Inhalation of 20K EU CCRE
Intervention Type
Biological
Intervention Name(s)
20K EU CCRE
Intervention Description
Inhalation of CCRE
Primary Outcome Measure Information:
Title
Increase in sputum neutrophils
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Mucociliary clearance rates
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Peden
Organizational Affiliation
University of NC Chapel Hill Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Center for Environmental Medicine, Asthma and Lung Biology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.med.unc.edu/cemalb
Description
Related Info
Learn more about this trial
A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers
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