Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: budesonide; Drug: budesonide/formoterol (Symbicort)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646321

D5896C00725

SD-039-0725

Details and patient eligibility

About

The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years

Enrollment: 540 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 6 and maximally 15 years of age
• Diagnosis of asthma and baseline lung function tests as determined by the protocol
• Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 2 patient groups

1

Experimental group

Description:

budesonide/formoterol

Treatment:

Drug: budesonide/formoterol (Symbicort)

2

Active Comparator group

Description:

budesonide

Treatment:

Drug: budesonide