Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma...
Brief Summary
Official Title: “Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).”
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
- 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: Salmeterol/fluticasone Diskus
Outcome Measures for this Clinical Trial
Primary Measures
- Time to first severe asthma exacerbation
Secondary Measures
- Number of severe asthma exacerbations
- Mild asthma exacerbations
- FEV1
- Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
- Healthcare utilization
- Safety (adverse events)
- - all variables assessed over the 6 months treatment period
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosed with asthma since at least 6 months prior to first visit
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
- At least one asthma exacerbation more than one but less than twelve months prior to first visit
Exclusion Criteria:
- Respiratory infection affecting asthma within 30 days before first visit
- Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
- Any significant disease or disorder that may jeopardize the safety of the patient
- Additional inclusion and exclusion criteria will be evaluated by the Investigator.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
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/NCT00242775
Study ID Number: D5890C00002
ClinicalTrials.gov Identifier: NCT00242775
Health Authority: Canada: Health Canada
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00242775
