Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

GlaxoSmithKline150 enrolled

Overview

This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone propionate/salmeterol combination DISKUSDRUG

salmeterol xinafoateDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis of COPD. Exclusion criteria: * Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. * Other inclusion and exclusion criteria will be evaluated at the first study visit.

Locations (2)

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Outcomes

Primary Outcomes

Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg

Secondary Outcomes

Change in morning PEF

Changes in pre-dose FVC, V50, V25

Use of rescue medication

Changes in symptom scores

Data from ClinicalTrials.gov

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