Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Budesonide inhalation suspension

Group Type EXPERIMENTAL

Budesonide inhalation suspension

Intervention Type DRUG

0.5mg

2

Montelukast sodium

Group Type ACTIVE_COMPARATOR

Montelukast Sodium

Intervention Type DRUG

4mg or 5mg

Interventions

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Budesonide inhalation suspension

0.5mg

Intervention Type DRUG

Montelukast Sodium

4mg or 5mg

Intervention Type DRUG

Other Intervention Names

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Pulmicort Respules SINGULAR

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No