Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652002

D5896C00717

SD-039-0717

Details and patient eligibility

About

The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults

Enrollment: 450 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 12 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

• 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
• 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: Triple Blind

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450 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: budesonide/formoterol

2

Active Comparator group

Description:

budesonide

Treatment:

Drug: budesonide

3

Active Comparator group

Description:

formoterol

Treatment:

Drug: formoterol