Atlantis Symbicort
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Last updated: March 26, 2009
|