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

Chronic Obstructive Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908362
• Other study ID #: LO-0003
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2009
• Last updated: January 12, 2010
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Germany	Dep. of Pneumology, University of Rostock	Rostock	Mecklenburg-Vorpommern

Sponsors (2)

Lead Sponsor	Collaborator
University of Rostock	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bratke K, Klug M, Bier A, Julius P, Kuepper M, Virchow JC, Lommatzsch M. Function-associated surface molecules on airway dendritic cells in cigarette smokers. Am J Respir Cell Mol Biol. 2008 Jun;38(6):655-60. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No