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Completed

NCT Number: NCT00908362

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

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.

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Key information

Conditions

Smoke-related Lung Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Dep. of Pneumology, University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone

Drug

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

fluticasone/salmeterol

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 25, 2009
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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