Trial intelligence / Profile preview

Symbicort pMDI Efficacy & Safety in Asthma

NCT00646516Phase 3

Key facts

Status: Completed
Start: Oct 2003
Sponsor: AstraZeneca
Modality: Orthosteric Ligands

Drugs: budesonide
Conditions: asthma

Overview

Phase 3, randomised, double-blind trial of budesonide in asthma (4 arms), sponsored by AstraZeneca. Primary endpoint: Change from start of treatment in evening pre-dose FEV1 at 12 weeks. Started Oct 2003; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Symbicort 2x160/4.5 QD
Symbicort pMDI 2 inhalations of 160/4.5 mcg Once Daily
Symbicort 2x80/4.5 QD
Symbicort pMDI 2 inhalations of 80/4.5 mcg Once Daily
Symbicort 2x80/4.5 BID
Symbicort pMDI 2 inhalations of 80/4.5 mcg Twice Daily
Budesonide 2x160 QD
Budesonide pMDI 2 inhalations of 160 mcg Once Daily

Who it enrols

Adults and adolescents (12 years and older) with mild or moderate asthma who have required and received treatment with inhaled corticosteroids.

Endpoints

Primary

Change from start of treatment in evening pre-dose FEV112 weeks

Secondary

Change from before treatment in lung functionDaily
Change from before treatment in symptomsDaily
Change from before treatment in use of rescue medicationDaily
Investigate safety profile of Symbicort and budesonide1 week post-treatment

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