Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646529

D5896C00719

SD-039-0719

Details and patient eligibility

About

The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Enrollment: 175 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 6 and maximally 11 years of age
• Diagnosis of asthma
• Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start

Exclusion criteria

• Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
• Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 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 (Pulmicort)