NCT00840723

Brief Summary

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

4.5 years

First QC Date

February 6, 2009

Last Update Submit

September 3, 2013

Conditions

Respiratory Diseases

Keywords

Healthy smokersCurrent cigarette smokersNo lung disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the time of bronchoscopy

Study Arms (2)

Current smokers

Current cigarette smokers with no other illness

Healthy controls

Healthy non smokers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Asthma
  • Smoking related lung disease (including bronchitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

  • Raymond Coakley, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 10, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)