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.”

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Inhalation of Fluticasone (via discus) twice daily for 28 days
• Active Comparator: B
  • Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days
• Placebo Comparator: C
  • Inhalation of Placebo (via discus) twice daily for 28 days.

Primary Measures

• 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.
  • Time Frame: 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).
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 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).
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Rostock

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00908362

Study ID Number: LO-0003

ClinicalTrials.gov Identifier: NCT00908362

Health Authority: Germany: Federal Institute for Drugs and Medical Devices