Titratable Dosing in Moderate to Severe Asthmatics
Phase 3
Completed
- Conditions
- Asthma
- Interventions
- Drug: budesonide/formoterolDrug: Symbicort pMDI + budesonide HFA pMDI
- Registration Number
- NCT00651768
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
Inclusion Criteria
- Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
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Exclusion Criteria
- Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
- Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 budesonide/formoterol - 2 Symbicort pMDI + budesonide HFA pMDI -
- Primary Outcome Measures
Name Time Method Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. 7 assessments within 12 month treatment period
- Secondary Outcome Measures
Name Time Method To measure changes in lung function tests, patient reported outcomes and usage of medical resource 7 assessments within 12 month treatment period Blood levels of budesonide and formoterol 10 blood samples taken at 1 visit in a sub-set of patients