Prevention of Asthma Relapse After Discharge From Emergency

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Gloria Jordana, MD, Study Director, Affiliation: AstraZeneca
Brian Rowe, MD, Principal Investigator, Affiliation: University of Alberta

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

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to first asthma relapse

Secondary outcome:

Mean use of reliever medication

Asthma Control Questionnaire (ACQ) score

Complete AE and SAE collection

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Research Site, Quebec, Canada

Research Site, Edmonton, Alberta, Canada

Research Site, St. Albert, Alberta, Canada

Research Site, Calgary, Alberta, Canada

Research Site, Lethbridge, Alberta, Canada

Research Site, Nanaimo, British Columbia, Canada

Research Site, Vancouver, British Columbia, Canada

Research Site, Halifax, Nova Scotia, Canada

Research Site, Truro, Nova Scotia, Canada

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

Research Site, Charlottetown, Prince Edward Island, Canada

Research Site, Montreal, Quebec, Canada

Research Site, La Malbaie, Quebec, Canada

Research Site, Ste-Foy, Quebec, Canada

Research Site, Saskatoon, Saskatchewan, Canada

Starting date: May 2006
Ending date: May 2007
Last updated: January 11, 2008