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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rostock
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

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