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Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

Phase 3
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Registration Number
NCT00549146
Lead Sponsor
GlaxoSmithKline
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
290
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
Secondary Outcome Measures
NameTimeMethod
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).

Trial Locations

Locations (1)

GSK Investigational Site

🇳🇱

Voerendaal, Netherlands

GSK Investigational Site
🇳🇱Voerendaal, Netherlands

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