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Acute Effects of Smoking on Airway Dendritic Cells

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Smoking
Smoking
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring Cigarette Smoking, Airway dendritic cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Active smoking (at least 10 cigarettes per day)
  • Age > 18 years

Exclusion Criteria:

  • Any chronic diseases
  • Any regular medication
  • Any signs or symptoms of an acute infection

Sites / Locations

  • University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1

2

Arm Description

Participants smoke 8 cigarettes in 4 hours.

Participants are not allowed to smoke for 4 hours.

Outcomes

Primary Outcome Measures

Total number of dendritic cells in bronchoalveolar lavage fluid

Secondary Outcome Measures

Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid

Full Information

First Posted
August 22, 2008
Last Updated
April 7, 2009
Sponsor
University of Rostock
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00740896
Brief Title
Acute Effects of Smoking on Airway Dendritic Cells
Official Title
Acute Effects of Smoking on Airway Dendritic Cells
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rostock
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Cigarette Smoking, Airway dendritic cells

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants smoke 8 cigarettes in 4 hours.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Participants are not allowed to smoke for 4 hours.
Intervention Type
Behavioral
Intervention Name(s)
Smoking
Intervention Description
Active Comparator: Participants smoke 8 cigarettes in 4 hours.
Intervention Type
Behavioral
Intervention Name(s)
Smoking
Intervention Description
Sham Comparator: Participants are not allowed to smoke for 4 hours.
Primary Outcome Measure Information:
Title
Total number of dendritic cells in bronchoalveolar lavage fluid
Time Frame
June - September 2008
Secondary Outcome Measure Information:
Title
Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid
Time Frame
June - September 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Active smoking (at least 10 cigarettes per day) Age > 18 years Exclusion Criteria: Any chronic diseases Any regular medication Any signs or symptoms of an acute infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann C. Virchow, Professor, MD, FRCP, FCCP
Organizational Affiliation
University of Rostock
Official's Role
Study Chair
Facility Information:
Facility Name
University of Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18203971
Citation
Bratke K, Klug M, Bier A, Julius P, Kuepper M, Virchow JC, Lommatzsch M. Function-associated surface molecules on airway dendritic cells in cigarette smokers. Am J Respir Cell Mol Biol. 2008 Jun;38(6):655-60. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18.
Results Reference
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Acute Effects of Smoking on Airway Dendritic Cells

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