Efficacy of Symbicort Versus Its Monocomponents

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-09-30

Brief Summary

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The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Symbicort

Group Type EXPERIMENTAL

budesonide/formoterol

Intervention Type DRUG

2

budesonide

Group Type ACTIVE_COMPARATOR

budesonide

Intervention Type DRUG

3

formoterol

Group Type ACTIVE_COMPARATOR

formoterol

Intervention Type DRUG

Interventions

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budesonide/formoterol

Intervention Type DRUG

budesonide

Intervention Type DRUG

formoterol

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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Inclusion Criteria

* At least 6 years of age
* Diagnosis of asthma
* Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol 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
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No