Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00641472

Collaborator

(none)

380

Enrollment

Arms

28.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Budesonide inhalation suspension Drug: Montelukast Sodium	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.

Study Start Date :

Oct 1, 2002

Actual Primary Completion Date :

Feb 1, 2005

Actual Study Completion Date :

Feb 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Budesonide inhalation suspension	Drug: Budesonide inhalation suspension 0.5mg Other Names: Pulmicort Respules
Active Comparator: 2 Montelukast sodium	Drug: Montelukast Sodium 4mg or 5mg Other Names: SINGULAR

Arm

Intervention/Treatment

Experimental: 1

Budesonide inhalation suspension

Drug: Budesonide inhalation suspension

0.5mg

Other Names:

Pulmicort Respules

Active Comparator: 2

Montelukast sodium

Drug: Montelukast Sodium

4mg or 5mg

Other Names:

SINGULAR

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence and Severity of Adverse Events [Each clinic visit]
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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