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

University of Rostock

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease; Smoke-related Lung Diseases

Treatments: Drug: placebo; Drug: fluticasone/salmeterol; Drug: fluticasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00908362

LO-0003

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Male

Ages: 30 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

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

Treatment:

Drug: fluticasone

B

Active Comparator group

Description:

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

Treatment:

Drug: fluticasone/salmeterol

C

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo