Asthma
Conditions
Keywords
Asthma, Ciclesonide, Child, Fluticasone propionate, Pediatric
Brief summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Interventions
DRUGCiclesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * History of persistent bronchial asthma for at least 6 months * FEV1 50-90% of predicted Main
Exclusion criteria
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function * Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study * History of life-threatening asthma * Premature birth * Current smoking * Smoking history with either equal or more than 10 pack-years * Pregnancy * Intention to become pregnant during the course of the study * Breast feeding * Lack of safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 absolute values | — |
| PD20FEV1 from methacholine challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| morning and evening PEF from diary | — |
| asthma symptom score from diary | — |
| salbutamol MDI use from diary | — |
| diurnal PEF fluctuation from diary | — |
| dropout rate due to asthma exacerbations and time to the first asthma exacerbation | — |
| percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control | — |
| FEV1 as % of predicted | — |
| interview administered PAQLQ(S), self-administered PACQLQ | — |
| physical examination and vital signs | — |
| laboratory investigation | — |
| AEs | — |
| HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples. | — |
| onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication | — |
| PEF from spirometry | — |
Countries
Brazil, Germany, Hungary, Poland, Portugal, South Africa
Outcome results
None listed