SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00361959
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.

Detailed Description

A Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE) 50/500mcg with Tiotropium Bromide 18 mcg on the Rate of Exacerbations in Subjects with Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1270

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

Name	Time	Method
Rate of healthcare utilisation based exacerbations of COPD

Secondary Outcome Measures

Name	Time	Method
Rates for exacerbations based on symptoms, treatment with oral corticosteroids and for antibioticsTime to next exacerbation, duration and difference between healthcare utilisation and symptom based exacerbation

Trial Locations

Locations (1)

GSK Investigational Site