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

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

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-08-31

Brief Summary

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

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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

DOUBLE

Study Groups

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1

budesonide/formoterol

Group Type EXPERIMENTAL

budesonide/formoterol (Symbicort)

Intervention Type DRUG

2

budesonide

Group Type ACTIVE_COMPARATOR

budesonide

Intervention Type DRUG

Interventions

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budesonide/formoterol (Symbicort)

Intervention Type DRUG

budesonide

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No