A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
Interventions
- Drug: Budesonide/Formoterol Turbuhaler
- Drug: Budesonide Turbuhaler (Pulmicort)
- Drug: Terbutaline Turbuhaler
Clinical Trial Outcome Measures
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
Participating 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: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- AstraZeneca
- Overall Official(s)
- AstraZeneca Symbicort Medical Science Director, MD, Study Director, AstraZeneca
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