Prevention of Asthma Relapse After Discharge From Emergency (PARADE)
January 21, 2011 updated by: AstraZeneca
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
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada
- Research Site
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Alberta
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Calgary, Alberta, Canada
- Research Site
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Edmonton, Alberta, Canada
- Research Site
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Lethbridge, Alberta, Canada
- Research Site
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St. Albert, Alberta, Canada
- Research Site
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British Columbia
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Nanaimo, British Columbia, Canada
- Research Site
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Vancouver, British Columbia, Canada
- Research Site
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Research Site
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Truro, Nova Scotia, Canada
- Research Site
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Ontario
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Hamilton, Ontario, Canada
- Research Site
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Kingston, Ontario, Canada
- Research Site
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Niagara Falls, Ontario, Canada
- Research Site
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Ottawa, Ontario, Canada
- Research Site
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Thunder Bay, Ontario, Canada
- Research Site
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Toronto, Ontario, Canada
- Research Site
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
- Research Site
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Quebec
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La Malbaie, Quebec, Canada
- Research Site
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Montreal, Quebec, Canada
- Research Site
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Ste-Foy, Quebec, Canada
- Research Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to first asthma relapse
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Secondary Outcome Measures
Outcome Measure |
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Mean use of reliever medication
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Asthma Control Questionnaire (ACQ) score
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Complete AE and SAE collection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gloria Jordana, MD, AstraZeneca
- Principal Investigator: Brian Rowe, MD, University of Alberta
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
May 12, 2006
First Submitted That Met QC Criteria
May 12, 2006
First Posted (Estimate)
May 16, 2006
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Recurrence
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
Other Study ID Numbers
- D5890L00017
- PARADE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.