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Atlantis Symbicort

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

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

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Mitchell Golmand, MD, Study Director, Affiliation: AstraZeneca
Catherine Bonuccelli, Study Chair, Affiliation: AstraZeneca

Summary

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

Clinical Details

Official title: A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Asthma control assessed by asthma exacerbations

Secondary outcome:

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.

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

Investigate safety profile of Symbicort compared to Advair

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2003
Ending date: June 2005
Last updated: March 27, 2008

Page last updated: June 20, 2008

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