A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5

AstraZeneca0 sites405 target enrollmentJuly 2002

ConditionsAsthma

Interventionsbudesonide/formoterol budesonide formoterol

Drugsbudesonide/formoterol budesonide formoterol

Overview

Phase: Phase 3
Intervention: budesonide/formoterol
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 405
Primary Endpoint: Morning PEF
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

October 2003

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Baseline lung function tests results as determined by the protocol
•Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria

•Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
•Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
•Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study