Asthma Clinical Trial
— PARADEOfficial 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
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | May 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Charlottetown | Prince Edward Island |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | La Malbaie | Quebec |
| Canada | Research Site | Lethbridge | Alberta |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Nanaimo | British Columbia |
| Canada | Research Site | Niagara Falls | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Saskatoon | Saskatchewan |
| Canada | Research Site | St. Albert | Alberta |
| Canada | Research Site | Ste-Foy | Quebec |
| Canada | Research Site | Thunder Bay | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Truro | Nova Scotia |
| Canada | Research Site | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first asthma relapse | |||
| Secondary | Mean use of reliever medication | |||
| Secondary | Asthma Control Questionnaire (ACQ) score | |||
| Secondary | Complete AE and SAE collection |
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