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Prevention of Asthma Relapse After Discharge From Emergency (PARADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326053
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : January 24, 2011
Information provided by:

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/formoterol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Drug: Budesonide/formoterol
    Other Name: Symbicort

Primary Outcome Measures :
  1. Time to first asthma relapse

Secondary Outcome Measures :
  1. Mean use of reliever medication
  2. Asthma Control Questionnaire (ACQ) score
  3. Complete AE and SAE collection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00326053

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Canada, Alberta
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Lethbridge, Alberta, Canada
Research Site
St. Albert, Alberta, Canada
Canada, British Columbia
Research Site
Nanaimo, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Research Site
Truro, Nova Scotia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Niagara Falls, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Thunder Bay, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Prince Edward Island
Research Site
Charlottetown, Prince Edward Island, Canada
Canada, Quebec
Research Site
La Malbaie, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Ste-Foy, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
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Study Director: Gloria Jordana, MD AstraZeneca
Principal Investigator: Brian Rowe, MD University of Alberta

Layout table for additonal information Identifier: NCT00326053    
Other Study ID Numbers: D5890L00017
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Asthma Reoccurrence
Acute Asthma
Patient Discharge
Emergency Service, Hospital
Asthma Exacerbation
Asthma Relapse
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Disease Attributes
Pathologic Processes
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents