Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics

GlaxoSmithKline1 site in 1 country700 target enrollmentNovember 2002

ConditionsAsthma

InterventionsSalmeterol/fluticasone propionate or formoterol/budesonide

DrugsSalmeterol/fluticasone propionate or formoterol/budesonide

Overview

Phase: Phase 4
Intervention: Salmeterol/fluticasone propionate or formoterol/budesonide
Conditions: Asthma
Sponsor: GlaxoSmithKline
Enrollment: 700
Locations: 1
Primary Endpoint: Mean percentage of symptom-free days over a 52-week treatment period
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan

Detailed Description

A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

July 2004

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented clinical history of asthma
•Forced expiratory volume in 1 second between 60% and 90% of predicted
•Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS alone at a dose equivalent to \>500 to 1000mcg daily of BDP daily

Exclusion Criteria

•Lower respiratory tract infection within 1 month of study entry
•Use of systemic corticosteroids within 1 month of study entry
•Smoking history of 10 pack years or more Changes in regular asthma therapy within 12 weeks of study entry
•Any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes

Arms & Interventions

Arm 1

Intervention: Salmeterol/fluticasone propionate or formoterol/budesonide

Outcomes

Primary Outcomes

Mean percentage of symptom-free days over a 52-week treatment period

Secondary Outcomes

Mean percentage of rescue-free days Daily asthma symptom scores Daily rescue usage Mean morning peak flow Percentage of nights awoken due to asthma Rate of exacerbations Airway hyper-responsiveness(PC20 AMP)