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

Study Overview
=================
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.

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.

Conditions
-----------------
Smoke-related Lung Diseases, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: fluticasone
* Drug: fluticasone/salmeterol
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Inhalation of Fluticasone (via discus) twice daily for 28 days | Drug: fluticasone<br>* Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.<br>|
| Active Comparator: B<br>Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days | Drug: fluticasone/salmeterol<br>* Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.<br>|
| Placebo Comparator: C<br>Inhalation of Placebo (via discus) twice daily for 28 days. | Drug: placebo<br>* Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dendritic cells, Airway, Smoker, COPD