Prevention of Asthma Relapse After Discharge From Emergency (PARADE)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00326053
First received: May 12, 2006
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Asthma
Drug: Budesonide/formoterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first asthma relapse

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

Estimated Enrollment: 600
Study Start Date: May 2006
Study Completion Date: May 2007
Intervention Details:
    Drug: Budesonide/formoterol
    Other Name: Symbicort
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326053

Locations
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
Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Gloria Jordana, MD AstraZeneca
Principal Investigator: Brian Rowe, MD University of Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00326053     History of Changes
Other Study ID Numbers: D5890L00017, PARADE
Study First Received: May 12, 2006
Last Updated: January 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
Asthma Reoccurrence
Acute Asthma
Patient Discharge
Emergency Service, Hospital
Asthma Exacerbation
Asthma Relapse

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 29, 2014