A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide/Formoterol Turbuhaler (Symbicort) (Drug); Budesonide Turbuhaler (Pulmicort) (Drug); Terbutaline Turbuhaler (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary outcome: Immunopathology and remodeling in biopsiesImmunopathology and mediators in induced sputum Severe asthma exacerbations (number of and time to first) Forced expiratory volume in 1 second (FEV1) As-needed use Safety variables, including adverse events and vital signs All variables assessed over the 12-month treatment period
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of asthma for at least 6 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one
Exclusion Criteria:
- 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
Locations and Contacts
Research Site, Ã…lborg, Denmark
Research Site, Ã…rhus C, Denmark
Research Site, Copenhagen, Denmark
Research Site, Montpellier, France
Research Site, Pessac, France
Research Site, Hannover, Germany
Research Site, Mainz, Germany
Research Site, Marburg, Germany
Research Site, Barcelona No. 40, Spain
Research Site, Barcelona, No. 42, Spain
Research Site, Baraclado, Spain
Research Site, Göteborg, Sweden
Research Site, Lund, Sweden
Research Site, Stockholm, Sweden
Research Site, Umeå, Sweden
Research Site, Uppsala, Sweden
Research Site, Leicester, United Kingdom
Research Site, Glasgow, United Kingdom
Research Site, London, United Kingdom
Research Site, Manchester, United Kingdom
Research Site, Newcastle-Upon-Tyne, United Kingdom
Research Site, Southampton, United Kingdom
Additional Information
Starting date: May 2005
Ending date: October 2007
Last updated: January 11, 2008
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