Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

GlaxoSmithKline130 enrolled

Overview

This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways disease

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol/fluticasone propionate 50/500mcg DiskusDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Established clinical history of chronic obstructive airways disease. * Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years). * Must have reduced lung function, defined as a Forced Expiratory Volume in 1 second (FEV1) of between 40-80% of predicted normal values. Exclusion Criteria: * Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.

Locations (20)

GSK Investigational Site

Aalborg, Denmark

GSK Investigational Site

København NV, Denmark

Outcomes

Primary Outcomes

To compare the number of CD68+ and CD8+ inflammatory cells per area of biopsy tissue and the percentage and total number of neutrophils in induced sputum between salmeterol/fluticasone propionate and placebo

Secondary Outcomes

To compare the number of mast cells, CD45+,CD4+,IFN-gamma mRNA+,TNF-alpha mRNA+, per area of biopsy and the percentage and number of macrophages, eosinophils, lymphocytes in induced sputum between salmeterol/fluticasone propionate and placebo

Data from ClinicalTrials.gov

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