Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects (SCCOR Bronch)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raymond Coakley, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00840723
First received: February 6, 2009
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

The purpose of this research study is to collect cells and liquid from the air passages of healthy adults, both smokers and non-smokers. These samples will be used for test-tube studies to explore mechanisms of diseases of the respiratory tract, and to compare the samples between people who smoke cigarettes and people who don't. Obtaining these samples requires an invasive procedure called "bronchoscopy".


Condition
Respiratory Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Bronchoscopy-Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects

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

Primary Outcome Measures:
  • The goal of this project is to define the effect of smoking on key aspects of airway biology. These studies will also provide crucial & novel definition of airway biology in smokers against which COPD & CF patients will be compared. [ Time Frame: At the time of bronchoscopy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, Bronchial Lavage Fluid (BALF), cytology brushings


Enrollment: 30
Study Start Date: February 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Current smokers
Current cigarette smokers with no other illness
Healthy controls
Healthy non smokers

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Current cigarette smokers who are otherwise healthy (no lung disease or other chronic illness and healthy controls

Criteria

Inclusion Criteria:

  • Current cigarette smokers
  • Must be otherwise healthy with no chronic illness

Exclusion Criteria:

  • Asthma
  • Smoking related lung disease (including bronchitis)
  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: NCT00840723

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: Raymond Coakley, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Raymond Coakley, MD, Assistant Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00840723     History of Changes
Other Study ID Numbers: CTRC 2799, NHLBI P50-HL084934
Study First Received: February 6, 2009
Last Updated: September 3, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Healthy smokers
Current cigarette smokers
No lung disease

Additional relevant MeSH terms:
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on October 01, 2014