NCT00740896

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Shorter than P25 for not_applicable

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

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

5 months

First QC Date

August 22, 2008

Last Update Submit

April 7, 2009

Conditions

Tobacco Use Disorder

Keywords

Cigarette SmokingAirway dendritic cells

Outcome Measures

Primary Outcomes (1)

  • Total number of dendritic cells in bronchoalveolar lavage fluid

    June - September 2008

Secondary Outcomes (1)

  • Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid

    June - September 2008

Study Arms (2)

1

ACTIVE COMPARATOR

Participants smoke 8 cigarettes in 4 hours.

Behavioral: Smoking

2

SHAM COMPARATOR

Participants are not allowed to smoke for 4 hours.

Behavioral: Smoking

Interventions

SmokingBEHAVIORAL

Active Comparator: Participants smoke 8 cigarettes in 4 hours.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock

Rostock, 18057, Germany

Location

Related Publications (1)

  • 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.

    PMID: 18203971BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderCigarette Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersTobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Johann C. Virchow, Professor, MD, FRCP, FCCP

    University of Rostock

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

DE(1)