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Chronic Obstructive Pulmonary Disease Endpoints Study

Phase 4
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Registration Number
NCT00358358
Lead Sponsor
GlaxoSmithKline
Brief Summary

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

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)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
163
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Peripheral airway resistance measured by IOS
Secondary Outcome Measures
NameTimeMethod
Airway wall thickness measured by CT scans

Trial Locations

Locations (1)

GSK Investigational Site

🇷🇺

Nizhnekamsk, Russian Federation

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