NCT00908362

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Rostock · Academic / Other
• Sex: Male
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoke-related Lung Diseases
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2009-05-25
• Last updated: 2010-01-13

Locations

1 site across 1 country: Germany