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

AstraZeneca540 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

540

Conditions

Asthma

Interventions

budesonide/formoterol (Symbicort)DRUG

budesonideDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in evening PEF

Time frame: Daily throughout the 12 week treatment period

Secondary Outcomes

Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes

Time frame: Daily throughout the 12 week treatment period

Routine safety assessments described in the protocol

Time frame: 2-4 assessments within 12 week treatment period

Data from ClinicalTrials.gov

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