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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
1,000
Efficacy and Safety of Ciclesonide
Placebo
time to first moderate or severe asthma exacerbation.
Time frame: 24 weeks
rate of patients with moderate or severe asthma exacerbation
Time frame: 24 weeks
rate of patients with moderate asthma exacerbation
Time frame: 24 weeks
rate of patients with severe asthma exacerbation
Time frame: 24 weeks
time to first moderate asthma exacerbation
Time frame: 24 weeks
time to first severe asthma exacerbation
Time frame: 24 weeks
asthma symptom score from diary
Time frame: 24 weeks
use of rescue medication
Time frame: 24 weeks
patient perceived asthma control
Time frame: 24 weeks
quality of life data (PACQLQ)
Time frame: 24 weeks
morning and evening PEF from diary
Time frame: 24 weeks
pulmonary function variables measured at the investigational sites
Time frame: 24 weeks
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Altana Pharma/Nycomed
Campinas - SP, Brazil
Altana Pharma/Nycomed
Curitiba-PR, Brazil
Altana Pharma/Nycomed
Paraná, Brazil
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil
Altana Pharma/Nycomed
Recife-PE, Brazil
Altana Pharma/Nycomed
Rio de Janeiro-RJ, Brazil
Altana Pharma/Nycomed
Rio Grande, Brazil
Altana Pharma/Nycomed
Salvador - Bahia, Brazil
...and 86 more locations
adverse events
Time frame: 24 weeks
physical examination
Time frame: 24 weeks
vital signs
Time frame: 24 weeks
laboratory work-up
Time frame: 24 weeks
serum cortisol
Time frame: 24 weeks
urine cortisol variables
Time frame: 24 weeks
body growth determined by stadiometry.
Time frame: 24 weeks