Atlantis Symbicort

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: budesonide/formoterol (Symbicort); Drug: fluticasone/salmeterol (Advair)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646594

D5896C00005

Details and patient eligibility

About

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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

1

Experimental group

Description:

budesonide/formoterol

Treatment:

Drug: budesonide/formoterol (Symbicort)

2

Active Comparator group

Description:

fluticasone/salmeterol

Treatment:

Drug: fluticasone/salmeterol (Advair)