A 12 Week Randomized, Double-blind, Double-Dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Children (at Least 6years of Age) and Adults With Asthma-SPRUCE 80/4.5

AstraZeneca0 sites450 target enrollmentAugust 2002

ConditionsAsthma

Overview

Phase: Phase 3
Intervention: budesonide/formoterol
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 450
Primary Endpoint: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
Status: Completed
Last Updated: 15 years ago

The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

September 2003

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•At least 6 years of age
•Diagnosis of asthma
•Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol

•Severe asthma
•Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
•Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator