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 Delivered Twice Daily Via the DISKUS/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline1 site1,270 target enrollmentJune 2003

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Enrollment: 1270
Locations: 1
Primary Endpoint: Rate of healthcare utilisation based exacerbations of COPD
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

February 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Rate of healthcare utilisation based exacerbations of COPD

Secondary Outcomes

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