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

Primary Purpose

Smoke-related Lung Diseases, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

fluticasone

fluticasone/salmeterol

placebo

About this trial

This is an interventional basic science trial for Smoke-related Lung Diseases focused on measuring Dendritic cells, Airway, Smoker, COPD

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Dep. of Pneumology, University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Inhalation of Fluticasone (via discus) twice daily for 28 days

Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days

Inhalation of Placebo (via discus) twice daily for 28 days.

Outcomes

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.

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.

Full Information

NCT ID

NCT00908362

First Posted

May 20, 2009

Last Updated

January 12, 2010

Sponsor

University of Rostock

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00908362

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Rostock

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoke-related Lung Diseases, Chronic Obstructive Pulmonary Disease

Keywords

Dendritic cells, Airway, Smoker, COPD

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Inhalation of Fluticasone (via discus) twice daily for 28 days

Arm Title

Arm Type

Active Comparator

Arm Description

Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days

Arm Title

Arm Type

Placebo Comparator

Arm Description

Inhalation of Placebo (via discus) twice daily for 28 days.

Intervention Type

Drug

Intervention Name(s)

fluticasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

fluticasone/salmeterol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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).

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Dep. of Pneumology, University of Rostock

City

Rostock

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

18057

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

18203971

Citation

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.

Results Reference

background

PubMed Identifier

24168756

Citation

Lommatzsch M, Kraeft U, Troebs L, Garbe K, Bier A, Stoll P, Klammt S, Kuepper M, Bratke K, Virchow JC. Fluticasone impact on airway dendritic cells in smokers: a randomized controlled trial. Respir Res. 2013 Oct 29;14(1):114. doi: 10.1186/1465-9921-14-114.

Results Reference

derived

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

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