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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908362
First Posted: May 25, 2009
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
University of Rostock
  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 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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). ]

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). ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908362


Locations
Germany
Dep. of Pneumology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Sponsors and Collaborators
University of Rostock
GlaxoSmithKline
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Rostock
ClinicalTrials.gov Identifier: NCT00908362     History of Changes
Other Study ID Numbers: LO-0003
First Submitted: May 20, 2009
First Posted: May 25, 2009
Last Update Posted: January 13, 2010
Last Verified: May 2009

Keywords provided by University of Rostock:
Dendritic cells
Airway
Smoker
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics