Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers - Full Text View

Sponsor:	University of Rostock
Collaborator:	GlaxoSmithKline
Information provided by:	University of Rostock
ClinicalTrials.gov Identifier:	NCT00908362

Purpose

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	Intervention	Phase
Smoke-related Lung Diseases Chronic Obstructive Pulmonary Disease	Drug: fluticasone Drug: fluticasone/salmeterol Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Smoking

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by University of Rostock:

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. [ 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). ] [ Designated as safety issue: No ]

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. [ 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). ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	May 2009
Study Completion Date:	December 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908362

Locations

Germany
Dep. of Pneumology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18057

Sponsors and Collaborators

University of Rostock

GlaxoSmithKline

More Information

Publications:

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. Epub 2008 Jan 18.

Responsible Party:	University of Rostock
ClinicalTrials.gov Identifier:	NCT00908362 History of Changes
Other Study ID Numbers:	LO-0003
Study First Received:	May 20, 2009
Last Updated:	January 12, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:

Dendritic cells
Airway
Smoker
COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on February 09, 2012