Asthma
Conditions
Keywords
Asthma, Pulmicort, budesonide, respules, turbuhaler
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.
Interventions
DRUGBudesonide
0.5mg once daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed