A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers (IRB 09-0259)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David B. Peden, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00924768
First received: June 17, 2009
Last updated: August 3, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Cigarette Smoking
Biological: 20K EU CCRE
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Study of Inhalation of 20,000 EU CCRE and MCC in Otherwise Healthy Individuals Who Are Current Cigarette Smokers

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Increase in sputum neutrophils [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mucociliary clearance rates [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endotoxin
Inhalation of 20K EU CCRE
Biological: 20K EU CCRE
Inhalation of CCRE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924768

Locations
United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David Peden University of NC Chapel Hill Hospitals
  More Information

Additional Information:
No publications provided

Responsible Party: David B. Peden, MD, Professor of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00924768     History of Changes
Other Study ID Numbers: BB9998 Protocol 14, NHLBI P50-HL084934
Study First Received: June 17, 2009
Last Updated: August 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Otherwise healthy current cigarette smokers
current cigarette smokers

ClinicalTrials.gov processed this record on September 16, 2014