Asthma
Conditions
Brief summary
The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Children of asthmatic mothers form the COPSAC birth cohort study
Exclusion criteria
* Children born more than 4 weeks preterm * children with other systemic illness that atopy/allergy * Children requiring mechanical ventilation at any time since birth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom free days | — |
| days with no use of bronchodilator | — |
| days with no use of bronchodilator and no symptoms | — |
| number of treated episodes | — |
| number of treatment with add-on medication | — |
Secondary
| Measure | Time frame |
|---|---|
| number of days with use of bronchodilator | — |
| number of patients who needed add-on medication | — |
| asthma status | — |
| height | — |
| serious adverse events | — |
| BMD | — |
| time to start of algorithm treatment | — |
| the total steroid dose | — |
| First treatment episode: | — |
| number of symptom days | — |
Countries
Denmark
Outcome results
None listed