Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651651

D5896C00716

SD-039-0716

Details and patient eligibility

About

The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults

Enrollment: 450 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 6 years of age
• Diagnosis of asthma
• Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol 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
• Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups

1

Experimental group

Description:

Symbicort

Treatment:

Drug: budesonide/formoterol

2

Active Comparator group

Description:

budesonide

Treatment:

Drug: budesonide

3

Active Comparator group

Description:

formoterol

Treatment:

Drug: formoterol