A Phase 3 interventional study of Ciclesonide and Placebo in Asthma, sponsored by AstraZeneca. Completed at 96 sites in 9 countries. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by AstraZeneca · Phase 3 and Interventional
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Ciclesonide 40 µg
Drug: Ciclesonide
Ciclesonide 80 µg
Drug: Ciclesonide
Ciclesonide 160 µg
Drug: Ciclesonide
Placebo
Drug: Placebo
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
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
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ciclesonide