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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Smoke-related Lung Diseases
• Interventions: Drug: fluticasone; Drug: fluticasone/salmeterol; Drug: placebo

• Registration Number: NCT00908362
• Lead Sponsor: University of Rostock

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-05
• Study Start: 2009-05
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	fluticasone	Inhalation of Fluticasone (via discus) twice daily for 28 days
B	fluticasone/salmeterol	Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days
C	placebo	Inhalation of Placebo (via discus) twice daily for 28 days.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

Dep. of Pneumology, University of Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany