Official Title: “A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)”

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic.

Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Salmeterol
• Drug: Fluticasone Propionate/Salmeterol Combination Product

Primary Measures

• Percent of sputum neutrophils

Secondary Measures

• Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms

Inclusion Criteria:

• Diagnosis of COPD.
• Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
• Ex-Smokers with at least a 10 pack-year history.

Exclusion Criteria:

• Current of secondary diagnosis of asthma or current diagnosis of atopy.
• Other respiratory disorders other than COPD.
• Other inflammatory diseases.
• Abnormal and clinically significant chest x-ray or ECG.
• Lung resection surgery within past 1 year.
• History of cancer not in remission within past 2 years.
• Serious, uncontrolled disease.
• Pregnancy or planning to become pregnant during the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Chair GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00346749

Study ID Number: ADC105931

ClinicalTrials.gov Identifier: NCT00346749

Health Authority: United States: Food and Drug Administration