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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT00908362
First received: May 20, 2009
Last updated: January 12, 2010
Last verified: May 2009
History of Changes
  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
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:

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:

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 June 17, 2013