Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

AstraZeneca450 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Asthma

Interventions

budesonide/formoterolDRUG

budesonideDRUG

formoterolDRUG

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation

Time frame: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period

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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