Official Title: “Evaluation of Novel Endpoints in Subjects With Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment With Fluticasone Propionate/Salmeterol 500/50mcg Combination (FSC 500/50) and Its Individual Components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)”

This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD.

COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination
• Drug: Fluticasone Propionate 500mcg
• Drug: Salmeterol 50mcg

Primary Measures

• Peripheral airway resistance measured by IOS

Secondary Measures

• Airway wall thickness measured by CT scans

Inclusion criteria:

• Diagnosis of COPD
• Current or ex-smoker at least 10 pack- years

Exclusion criteria:

• Diagnosis of asthma
• Active respiratory disorder other than COPD
• Evidence of clinically significant uncontrolled non-pulmonary disease
• Carcinoma not in complete remission for last 5 years
• Lung volume reduction surgery in previous 12 months
• Nocturnal positive pressure for sleep apnea
• Other inclusion and exclusion criteria will be evaluated at the first study visit.

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 Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00358358

Study ID Number: SCO104925

ClinicalTrials.gov Identifier: NCT00358358

Health Authority: United States: Food and Drug Administration