Prevention of Asthma Relapse After Discharge From Emergency - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00326053

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 III

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Terbutaline Terbutaline sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

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

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

Locations

Canada
Research Site
Quebec, Canada
Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Research Site
St. Albert, Alberta, Canada
Research Site
Calgary, Alberta, Canada
Research Site
Lethbridge, 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
Toronto, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Niagara Falls, Ontario, Canada
Research Site
Thunder Bay, Ontario, Canada
Canada, Prince Edward Island
Research Site
Charlottetown, Prince Edward Island, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Research Site
La Malbaie, Quebec, Canada
Research Site
Ste-Foy, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Gloria Jordana, MD	AstraZeneca
Principal Investigator:	Brian Rowe, MD	University of Alberta

More Information

Study ID Numbers:	D5890L00017, PARADE
Study First Received:	May 12, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00326053
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Asthma Reoccurrence
Acute Asthma
Patient Discharge

Emergency Service, Hospital
Asthma Exacerbation
Asthma Relapse

Study placed in the following topic categories:

Symbicort
Budesonide
Asthma
Recurrence
Terbutaline
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Emergencies
Formoterol
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Hormones
Glucocorticoids
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009