Chronic Obstructive Pulmonary Disease Endpoints Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination
* Drug: Fluticasone Propionate 500mcg
* Drug: Salmeterol 50mcg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination|nan|
|Drug: Fluticasone Propionate 500mcg|nan|
|Drug: Salmeterol 50mcg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral airway resistance measured by IOS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway wall thickness measured by CT scans |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Impulse Oscillometry System, Computerized Tomography