Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.

Detailed Description
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Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.

Official Title
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Multi-centre, DB, R and Stratified Parallel Group Study to Compare the Efficacy and Safety of FP 500mcg Bid vs. SRT 50/250mcg Via Diskus in COPD Pts With Partial Reversible Obstruction

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product
* Drug: fluticasone propionate DISKUS 500mcg


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Established history of chronic obstructive pulmonary disease (COPD). Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL. Signed and dated informed consent. Exclusion criteria: History of asthma or allergy. Unstable COPD in the 3 months before the study. Interference of non-pulmonary medication or diseases with COPD outcome parameters.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 250/50 DISKUS combination product|nan|
|Drug: fluticasone propionate DISKUS 500mcg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reversibility, COPD, lung function