Asthma
Conditions
Keywords
Asthma, Pulmicort, Children, paediatrics, budesonide
Brief summary
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.
Interventions
0.5mg
DRUGMontelukast Sodium
4mg or 5mg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Aged 2 to 8 at study entry * At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma * use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in
Exclusion criteria
* Severe or unstable asthma * any significant finding at a physical exam * an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids | Each clinic visit |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events | Each clinic visit |
| Time to 1st additional asthma medication measured at 12 weeks and 26 weeks | Each clinic visit |
| Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks | Each clinic visit |
Outcome results
None listed