Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

GlaxoSmithKline290 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

290

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone propionate/salmeterol 250/50 DISKUS combination productDRUG

fluticasone propionate DISKUS 500mcgDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (17)

GSK Investigational Site

Alkmaar, Netherlands

GSK Investigational Site

Almelo, Netherlands

GSK Investigational Site

Outcomes

Primary Outcomes

Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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