A 13-week, Double-blind, Parallel Group, Multi-centre Study to Compare the Bronchial Anti-inflammatory Activity of the Combination of Salmeterol/Fluticasone Propionate 50/500mcg Twice Daily Compared With Placebo Twice Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline1 site in 1 country130 target enrollmentOctober 2002

ConditionsPulmonary Disease, Chronic Obstructive

DrugsSalmeterol/fluticasone propionate 50/500mcg Diskus

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Enrollment: 130
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

December 2003

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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.

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