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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908362

Enrollment

Registered

2009-05-25

Start date

2009-05-31

Completion date

2009-12-31

Last updated

2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoke-related Lung Diseases, Chronic Obstructive Pulmonary Disease

Keywords

Dendritic cells, Airway, Smoker, COPD

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.

Interventions

DRUGfluticasone

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

DRUGfluticasone/salmeterol

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

30 Years to 60 Years

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

Design outcomes

Primary

Measure	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

Measure	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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026