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Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908362
First Posted: May 25, 2009
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
University of Rostock
May 20, 2009
May 25, 2009
January 13, 2010
May 2009
October 2009   (Final data collection date for primary outcome measure)
The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo. [ Time Frame: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy). ]
Same as current
Complete list of historical versions of study NCT00908362 on ClinicalTrials.gov Archive Site
The expression of other surface molecules on DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo. [ Time Frame: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy). ]
Same as current
Not Provided
Not Provided
 
Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers
Investigator Initiated, Placebo Controlled, Randomized Pilot Trial on the Influence of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers With COPD Stage GOLD 0 or 1.
Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway DCs in smokers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Smoke-related Lung Diseases
  • Chronic Obstructive Pulmonary Disease
  • Drug: fluticasone
    Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
  • Drug: fluticasone/salmeterol
    Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
  • Drug: placebo
    Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
  • Active Comparator: A
    Inhalation of Fluticasone (via discus) twice daily for 28 days
    Intervention: Drug: fluticasone
  • Active Comparator: B
    Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days
    Intervention: Drug: fluticasone/salmeterol
  • Placebo Comparator: C
    Inhalation of Placebo (via discus) twice daily for 28 days.
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men aged 30 - 60 years
  • At least 15 years of smoking
  • Current smoker, at least 10 cigarettes per day

Exclusion Criteria:

  • Any acute or chronic disease (except COPD oder hypertension)
  • Any regular medication (except drugs against hypertension)
  • FEV1 < 80% predicted
  • Oxygen saturation < 90%
  • Acute infections of the lower respiratory tract in the last 7 days before the first day of the study
Sexes Eligible for Study: Male
30 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00908362
LO-0003
No
Not Provided
Not Provided
University of Rostock
University of Rostock
GlaxoSmithKline
Not Provided
University of Rostock
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP