Official Title: “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)”

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

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus

Primary Measures

• 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 Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00268177

Study ID Number: SCO30005

ClinicalTrials.gov Identifier: NCT00268177

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency