Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide inhalation suspension; Drug: Montelukast Sodium

• Registration Number: NCT00641472
• Lead Sponsor: AstraZeneca

Brief Summary

A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Aged 2 to 8 at study entry
• At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
• use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in

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Exclusion Criteria

• Severe or unstable asthma
• any significant finding at a physical exam
• an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Budesonide inhalation suspension	Budesonide inhalation suspension
2	Montelukast Sodium	Montelukast sodium

Primary Outcome Measures

Name	Time	Method
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids	Each clinic visit

Secondary Outcome Measures

Name	Time	Method
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks	Each clinic visit
Incidence and Severity of Adverse Events	Each clinic visit
Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks	Each clinic visit