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Prevention of Asthma Relapse After Discharge From Emergency (PARADE)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Budesonide/formoterol
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma Reoccurrence, Acute Asthma, Patient Discharge, Emergency Service, Hospital, Asthma Exacerbation, Asthma Relapse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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Outcomes

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

Full Information

First Posted
May 12, 2006
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00326053
Brief Title
Prevention of Asthma Relapse After Discharge From Emergency
Acronym
PARADE
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma Reoccurrence, Acute Asthma, Patient Discharge, Emergency Service, Hospital, Asthma Exacerbation, Asthma Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol
Other Intervention Name(s)
Symbicort
Primary Outcome Measure Information:
Title
Time to first asthma relapse
Secondary Outcome Measure Information:
Title
Mean use of reliever medication
Title
Asthma Control Questionnaire (ACQ) score
Title
Complete AE and SAE collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Jordana, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brian Rowe, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Lethbridge
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
St. Albert
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Nanaimo
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Truro
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Niagara Falls
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Charlottetown
State/Province
Prince Edward Island
Country
Canada
Facility Name
Research Site
City
La Malbaie
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

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Prevention of Asthma Relapse After Discharge From Emergency

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