Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects (SCCOR Bronch)
This study is ongoing, but not recruiting participants.
Sponsor:
University of North Carolina, Chapel Hill
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: May 10, 2012
Last verified: May 2012
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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 |
Resource links provided by NLM:
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
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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
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: | May 10, 2012 |
| 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:
|
Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013