Acute Effects of Smoking on Airway Dendritic Cells

April 7, 2009 updated by: University of Rostock
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

  • Germany
      • Rostock, Germany, 18057
        • University of Rostock

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Participants smoke 8 cigarettes in 4 hours.
Behavioral: Smoking
Active Comparator: Participants smoke 8 cigarettes in 4 hours.
Behavioral: Smoking
Sham Comparator: Participants are not allowed to smoke for 4 hours.
Sham Comparator: 2
Participants are not allowed to smoke for 4 hours.
Behavioral: Smoking
Active Comparator: Participants smoke 8 cigarettes in 4 hours.
Behavioral: Smoking
Sham Comparator: Participants are not allowed to smoke for 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of dendritic cells in bronchoalveolar lavage fluid
Time Frame: June - September 2008
June - September 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid
Time Frame: June - September 2008
June - September 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Collaborators

German Research Foundation

Investigators

  • Study Chair: Johann C. Virchow, Professor, MD, FRCP, FCCP, University of Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2009

Last Update Submitted That Met QC Criteria

April 7, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LO-2222

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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