Asthma
Conditions
Keywords
Asthma, Ciclesonide, Child, Fluticasone propionate, HPA-axis, Pediatric, Linear growth rate
Brief summary
The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Interventions
DRUGCiclesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable * Prepubertal stage * Good health with the exception of asthma * History of asthma for at least 6 months * Currently using rescue medication only Main
Exclusion criteria
* Childbearing potential (beyond menarche) * Concurrent diseases or conditions which may subsequently affect growth * COPD or relevant lung diseases causing alternating impairment in lung function * Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * History of life-threatening asthma * Current smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| growth velocity of the right lower leg as measured by knemometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| weight and height | — |
| lung function from spirometry | — |
| asthma symptom score, use of rescue medication from diary | — |
| HPA-axis function | — |
| vital signs, including blood pressure, pulse rate | — |
| physical examination | — |
| laboratory investigation. | — |
| adverse events | — |
Countries
Denmark
Outcome results
None listed