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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: budesonide/formoterol (Symbicort); Drug: budesonide

• Registration Number: NCT00646321
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2004-08
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	budesonide/formoterol (Symbicort)	budesonide/formoterol
2	budesonide	budesonide

Primary Outcome Measures

Name	Time	Method
Change in evening PEF	Daily throughout the 12 week treatment period

Secondary Outcome Measures

Name	Time	Method
Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes	Daily throughout the 12 week treatment period
Routine safety assessments described in the protocol	2-4 assessments within 12 week treatment period