Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers
NCT ID: NCT00908362
Last Updated: 2010-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2009-05-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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A
Inhalation of Fluticasone (via discus) twice daily for 28 days
fluticasone
Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
B
Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days
fluticasone/salmeterol
Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
C
Inhalation of Placebo (via discus) twice daily for 28 days.
placebo
Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
Interventions
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fluticasone
Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
fluticasone/salmeterol
Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
placebo
Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
Eligibility Criteria
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Inclusion Criteria
* At least 15 years of smoking
* Current smoker, at least 10 cigarettes per day
Exclusion Criteria
* 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
30 Years
60 Years
MALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
University of Rostock
OTHER
Responsible Party
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University of Rostock
Locations
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Dep. of Pneumology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Countries
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References
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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.
Lommatzsch M, Kraeft U, Troebs L, Garbe K, Bier A, Stoll P, Klammt S, Kuepper M, Bratke K, Virchow JC. Fluticasone impact on airway dendritic cells in smokers: a randomized controlled trial. Respir Res. 2013 Oct 29;14(1):114. doi: 10.1186/1465-9921-14-114.
Other Identifiers
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LO-0003
Identifier Type: -
Identifier Source: org_study_id
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