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.

NCT00908362 Phase 1 COMPLETED

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.

Details

Lead sponsor	University of Rostock
Phase	Phase 1
Status	COMPLETED
Enrolment	45
Start date	2009-05
Completion	2009-12

Conditions

• Smoke-related Lung Diseases
• Chronic Obstructive Pulmonary Disease

Interventions

• fluticasone
• fluticasone/salmeterol
• placebo

Primary outcomes

• 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. — 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).

Countries

Germany