Adults With Moderate to Severe Asthma
- Registration Number
- NCT00642122
- Lead Sponsor
- AstraZeneca
- Brief Summary
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
- Male or female aged 12 or over who have asthma
- Ability to properly use an electronic diary
- Able and willing to nebulize for up to 20 minutes every morning and evening
Exclusion Criteria
- Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
- Planned hospitalisation during the study
- pregnant women or women planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Budesonide Pulmicort RESPULES 2 Budesonide Pulmicort TURBUHALER
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg. Day -14, 1, and every 28 days thereafter
- Secondary Outcome Measures
Name Time Method Percentage of symptom free days Day -14, 1, and every 28 days thereafter Percentage of symptom free nights Day -14, 1, and every 28 days thereafter Percentage of symptom free 24-hours Day -14, 1, and every 28 days thereafter