Atlantis Symbicort

AstraZeneca1,200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,200

Conditions

Asthma

Interventions

budesonide/formoterol (Symbicort)DRUG

fluticasone/salmeterol (Advair)DRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Asthma control assessed by asthma exacerbations

Time frame: Continuosly throughout the treatment period

Secondary Outcomes

Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.

Time frame: Daily and at 1, 3 and 6 months after start of treatmen

Use of medical resources and medication for the treatment of asthma.

Time frame: Throughout the treatment period

Investigate safety profile of Symbicort compared to Advair

Time frame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment

Data from ClinicalTrials.gov

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