NCT00326053

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

May 12, 2006

Last Update Submit

January 21, 2011

Conditions

Keywords

Asthma ReoccurrenceAcute AsthmaPatient DischargeEmergency Service, HospitalAsthma ExacerbationAsthma Relapse

Outcome Measures

Primary Outcomes (1)

  • Time to first asthma relapse

Secondary Outcomes (3)

  • Mean use of reliever medication

  • Asthma Control Questionnaire (ACQ) score

  • Complete AE and SAE collection

Interventions

Also known as: Symbicort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Presenting at a study emergency department with an asthma exacerbation

You may not qualify if:

  • Admission to hospital
  • Patients receiving more than 2000 µg/day of beclomethasone equivalent inhaled corticosteroids (1000 µg/day fluticasone or 1600 µg/day budesonide)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Calgary, Alberta, Canada

Location

Research Site

Edmonton, Alberta, Canada

Location

Research Site

Lethbridge, Alberta, Canada

Location

Research Site

St. Albert, Alberta, Canada

Location

Research Site

Nanaimo, British Columbia, Canada

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Truro, Nova Scotia, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Kingston, Ontario, Canada

Location

Research Site

Niagara Falls, Ontario, Canada

Location

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Thunder Bay, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Charlottetown, Prince Edward Island, Canada

Location

Research Site

La Malbaie, Quebec, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Ste-Foy, Quebec, Canada

Location

Research Site

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

AsthmaEmergencies

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Gloria Jordana, MD

    AstraZeneca

    STUDY DIRECTOR
  • Brian Rowe, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2007

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations