Symbicort in Asthmatic Children - SEEDLING

AstraZeneca405 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

405

Conditions

Asthma

Interventions

budesonide/formoterolDRUG

budesonideDRUG

formoterolDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Morning PEF

Time frame: Daily

Secondary Outcomes

Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments

Time frame: Throughout the treatment period

Data from ClinicalTrials.gov

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