The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort® Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the emergency...
Date First Received: May 12, 2006
Last Updated: January 11, 2008
Verified by: AstraZeneca, January 2008
Clinical Trial Phase: Phase 3 | Start Date: May 2006
Overall Status: Completed
Estimated Enrollment: 600
Brief Summary
Official Title: “A Comparison of Budesonide/Formoterol Turbuhaler® 160/4.5 µg 2 Inhalations BID Plus as Needed to Budesonide Turbuhaler® 320 µg 2 Inhalations BID Plus Terbutaline Turbuhaler® 0.4 mg as Needed for the Prevention of Asthma Relapse”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort® Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the emergency room
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: May 2007
Intervention(s) in this Clinical Trial
- Drug: Budesonide/formoterol
Outcome Measures for this Clinical Trial
Primary Measures
- Time to first asthma relapse
Secondary Measures
- Mean use of reliever medication
- Asthma Control Questionnaire (ACQ) score
- Complete AE and SAE collection
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 18 - 65 years of age
- Presenting at a study emergency department with an asthma exacerbation
Exclusion Criteria:
- Admission to hospital
- Patients receiving more than 2000 µg/day of beclomethasone equivalent inhaled corticosteroids (1000 µg/day fluticasone or 1600 µg/day budesonide)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Gloria Jordana, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00326053
Study ID Number: D5890L00017
ClinicalTrials.gov Identifier: NCT00326053
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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