Symbicort in Asthmatic Children - SEEDLING

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: formoterol; Drug: budesonide/formoterol; Drug: budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651547

D5896C00718

SD-039-0718

Details and patient eligibility

About

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

Enrollment: 405 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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405 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: budesonide/formoterol

2

Active Comparator group

Treatment:

Drug: budesonide

3

Active Comparator group

Treatment:

Drug: formoterol