Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
- Registration Number
- NCT00163449
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo Placebo 1 Ciclesonide Ciclesonide 40 µg 3 Ciclesonide Ciclesonide 160 µg 2 Ciclesonide Ciclesonide 80 µg
- Primary Outcome Measures
Name Time Method time to first moderate or severe asthma exacerbation. 24 weeks
- Secondary Outcome Measures
Name Time Method adverse events 24 weeks vital signs 24 weeks serum cortisol 24 weeks urine cortisol variables 24 weeks time to first moderate asthma exacerbation 24 weeks rate of patients with moderate or severe asthma exacerbation 24 weeks rate of patients with moderate asthma exacerbation 24 weeks morning and evening PEF from diary 24 weeks laboratory work-up 24 weeks rate of patients with severe 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 physical examination 24 weeks quality of life data (PACQLQ) 24 weeks pulmonary function variables measured at the investigational sites 24 weeks body growth determined by stadiometry. 24 weeks
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇨🇭Zürich, Switzerland