A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS
2 other identifiers
interventional
100
6 countries
22
Brief Summary
The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started May 2005
Typical duration for phase_3 asthma
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 25, 2005
CompletedFirst Posted
Study publicly available on registry
October 27, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJanuary 24, 2011
January 1, 2011
October 25, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary Outcomes (7)
Immunopathology and remodeling in biopsies
Immunopathology and mediators in induced sputum
Severe asthma exacerbations (number of and time to first)
Forced expiratory volume in 1 second (FEV1)
As-needed use
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma for at least 6 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one
You may not qualify if:
- Respiratory infection affecting asthma within 30 days prior to study
- Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
- Any significant disease or disorder that may jeopardize the safety of the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (22)
Research Site
Aalborg, Denmark
Research Site
Århus C, Denmark
Research Site
Copenhagen, Denmark
Research Site
Montpellier, France
Research Site
Pessac, France
Research Site
Hanover, Germany
Research Site
Mainz, Germany
Research Site
Marburg, Germany
Research Site
Baraclado, Spain
Research Site
Barcelona No. 40, Spain
Research Site
Barcelona, No. 42, Spain
Research Site
Gothenburg, Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
Research Site
Glasgow, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Research Site
Southampton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Symbicort Medical Science Director, MD
AstraZeneca
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
October 25, 2005
First Posted
October 27, 2005
Study Start
May 1, 2005
Study Completion
March 1, 2007
Last Updated
January 24, 2011
Record last verified: 2011-01