Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

AstraZeneca380 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

380

Conditions

Asthma

Interventions

Budesonide inhalation suspensionDRUG

0.5mg

Montelukast SodiumDRUG

4mg or 5mg

Eligibility

Sex: ALLMin age: 2 YearsMax age: 8 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids

Time frame: Each clinic visit

Secondary Outcomes

Incidence and Severity of Adverse Events

Time frame: Each clinic visit

Time to 1st additional asthma medication measured at 12 weeks and 26 weeks

Time frame: 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

Time frame: Each clinic visit

Data from ClinicalTrials.gov

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