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

University of Rostock45 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Interventions

fluticasoneDRUG

Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.

fluticasone/salmeterolDRUG

Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.

placeboDRUG

Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dep. of Pneumology, University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Outcomes

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.

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).

Secondary Outcomes

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.