Asthma
Conditions
Keywords
Asthma, Ciclesonide, Child, Pediatric
Brief summary
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Interventions
DRUGCiclesonide
Efficacy and Safety of Ciclesonide
DRUGPlacebo
Placebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Written informed consent by the parents or legal guardians of the patient * Outpatients * Good health with the exception of asthma * Documented diagnosis of asthma for more than 6 months * Use of rescue medication only or pretreatment with a controller drug Main
Exclusion criteria
* Concomitant severe diseases * Diseases contraindicated for the use of inhaled steroids * Other relevant lung diseases causing impairment in pulmonary function * Recurrent, episodic wheezing only * History of life-threatening asthma * History of any mechanical ventilation * Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation * Premature birth (\< 32 weeks gestation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to first moderate or severe asthma exacerbation. | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| rate of patients with moderate asthma exacerbation | 24 weeks |
| rate of patients with severe asthma exacerbation | 24 weeks |
| time to first moderate asthma exacerbation | 24 weeks |
| time to first severe asthma exacerbation | 24 weeks |
| asthma symptom score from diary | 24 weeks |
| use of rescue medication | 24 weeks |
| patient perceived asthma control | 24 weeks |
| quality of life data (PACQLQ) | 24 weeks |
| rate of patients with moderate or severe asthma exacerbation | 24 weeks |
| pulmonary function variables measured at the investigational sites | 24 weeks |
| adverse events | 24 weeks |
| physical examination | 24 weeks |
| vital signs | 24 weeks |
| laboratory work-up | 24 weeks |
| serum cortisol | 24 weeks |
| urine cortisol variables | 24 weeks |
| body growth determined by stadiometry. | 24 weeks |
| morning and evening PEF from diary | 24 weeks |
Countries
Brazil, Germany, Hungary, India, Netherlands, Poland, South Africa, Spain, Switzerland
Outcome results
None listed