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
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Mitchell Golmand, MD, Study Director, Affiliation: AstraZeneca
Catherine Bonuccelli, Study Chair, Affiliation: AstraZeneca
The purpose of this study is to determine whether Symbicort compared with Advair, will be
more effective in controlling asthma in adults and adolescents.
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
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
Minimum age: 12 Years.
Maximum age: N/A.
- 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
- Has required treatment with any non-inhaled corticosteroid within previous 30 days,
sensitivity to drugs specified in the protocol, or requires treatment with a
- Had cancer within previous 5 years or currently has any other significant disease or
disorder as judged by the investigator
Locations and Contacts
Starting date: November 2003
Ending date: June 2005
Last updated: March 27, 2008