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

Sponsor

University of Rostock (Other)

Overall Status

Completed

CT.gov ID

NCT00908362

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arms

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoke-related Lung Diseases Chronic Obstructive Pulmonary Disease	Drug: fluticasone Drug: fluticasone/salmeterol Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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.

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: A

Inhalation of Fluticasone (via discus) twice daily for 28 days

Drug: fluticasone

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

Active Comparator: B

Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days

Drug: fluticasone/salmeterol

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

Placebo Comparator: C

Inhalation of Placebo (via discus) twice daily for 28 days.

Drug: placebo

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

Outcome Measures

Primary Outcome 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. [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

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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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