- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00840723
Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects (SCCOR Bronch)
September 3, 2013 updated by: Raymond Coakley, MD, University of North Carolina, Chapel Hill
Bronchoscopy-Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human Subjects
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".
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Center for Environmental Medicine, Asthma and Lung Biology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Current cigarette smokers who are otherwise healthy (no lung disease or other chronic illness and healthy controls
Description
Inclusion Criteria:
- Current cigarette smokers
- Must be otherwise healthy with no chronic illness
Exclusion Criteria:
- Asthma
- Smoking related lung disease (including bronchitis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Current smokers
Current cigarette smokers with no other illness
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Healthy controls
Healthy non smokers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At the time of bronchoscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Raymond Coakley, MD, University of North Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
February 6, 2009
First Submitted That Met QC Criteria
February 9, 2009
First Posted (Estimate)
February 10, 2009
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 3, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTRC 2799
- NHLBI P50-HL084934
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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