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

Information source: University of Rostock
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: University of Rostock

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

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

Dep. of Pneumology, University of Rostock, Rostock, Mecklenburg-Vorpommern 18057, Germany
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. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18.

Starting date: May 2009
Last updated: January 12, 2010

Page last updated: August 23, 2015

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