A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Budesonide/Formoterol Turbuhaler
- Drug: Budesonide Turbuhaler (Pulmicort)
- Drug: Terbutaline Turbuhaler
Outcome Measures for this Clinical Trial
Primary Measures
- Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary Measures
- 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
- Safety variables, including adverse events and vital signs
- All variables assessed over the 12-month treatment period
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
AstraZeneca Symbicort Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00244608
Study ID Number: D5890C00003
ClinicalTrials.gov Identifier: NCT00244608
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00244608
