Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers
Information source: University of Rostock
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoke-Related Lung Diseases; Chronic Obstructive Pulmonary Disease
Intervention: fluticasone (Drug); fluticasone/salmeterol (Drug); placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Rostock Overall contact:
Marek Lommatzsch, MD, Phone: 0049 -381- 494-7461, Email: marek.lommatzsch@med.uni-rostock.de
Summary
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.
Clinical Details
Official title: 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.
Study design: Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 30 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Marek Lommatzsch, MD, Phone: 0049 -381- 494-7461, Email: marek.lommatzsch@med.uni-rostock.de
Dep. of Pneumology, University of Rostock, Rostock, Mecklenburg-Vorpommern 18057, Germany; Recruiting
Marek Lommatzsch, MD, Phone: 0049-381-494-7461, Email: marek.lommatzsch@med.uni-rostock.de
Additional Information
Related publications: 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. Epub 2008 Jan 18.
Starting date: May 2009
Ending date: December 2009
Last updated: May 22, 2009
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