NCT00238784

Brief Summary

The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,300

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started May 2004

Geographic Reach
1 country

3 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, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

Enrollment Period

1.4 years

First QC Date

October 12, 2005

Last Update Submit

January 11, 2008

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Time to first severe asthma exacerbation

Secondary Outcomes (8)

  • Number of asthma exacerbations

  • Mean use of as-needed medication

  • Prescribed asthma medication

  • Patient reported Outcomes

  • Health care resource use

  • +3 more secondary outcomes

Interventions

Budesonide/formoterol TurbuhalerDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma \< 3 months
  • Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

You may not qualify if:

  • Smoking history \> 10 pack-years
  • Any significant disease or disorder that my jeopardize the safety of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Aldergrove, British Columbia, Canada

Location

Research Site

Bolton, Ontario, Canada

Location

Research Site

Brampton, Ontario, Canada

Location

Related Publications (1)

  • Sears MR, Boulet LP, Laviolette M, Fitzgerald JM, Bai TR, Kaplan A, Smiljanic-Georgijev N, Lee JS. Budesonide/formoterol maintenance and reliever therapy: impact on airway inflammation in asthma. Eur Respir J. 2008 May;31(5):982-9. doi: 10.1183/09031936.00104007. Epub 2008 Jan 23.

    PMID: 18216054DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • AstraZeneca Rita Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

May 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

CA(3)