Clinical trial NCT00326053: Prevention of Asthma Relapse After Discharge From Emergency
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma Reoccurrence
Acute Asthma
Patient Discharge
Emergency Service, Hospital
Asthma Exacerbation
Asthma Relapse
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Time to first asthma relapse
Secondary outcomes:
measure: Mean use of reliever medication
measure: Asthma Control Questionnaire (ACQ) score
measure: Complete AE and SAE collection
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Lethbridge
country: Canada
facility: Research Site
state: Alberta
city: St. Albert
country: Canada
facility: Research Site
state: Alberta
city: Nanaimo
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Truro
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Charlottetown
country: Canada
facility: Research Site
state: Prince Edward Island
city: La Malbaie
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Gloria Jordana, MD
role: STUDY_DIRECTOR
affiliation: University of Alberta
name: Brian Rowe, MD
role: PRINCIPAL_INVESTIGATOR
References: