Atlantis Symbicort

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

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-01-31

Brief Summary

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The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

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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/formoterol

Group Type EXPERIMENTAL

budesonide/formoterol (Symbicort)

Intervention Type DRUG

2

fluticasone/salmeterol

Group Type ACTIVE_COMPARATOR

fluticasone/salmeterol (Advair)

Intervention Type DRUG

Interventions

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budesonide/formoterol (Symbicort)

Intervention Type DRUG

fluticasone/salmeterol (Advair)

Intervention Type DRUG

Other Intervention Names

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Symbicort Advair

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of asthma
* Baseline lung function tests as determined by protocol
* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

Exclusion Criteria

* Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a 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

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No