Study identifier:EFC6695
ClinicalTrials.gov identifier:NCT00392288
EudraCT identifier:N/A
CTIS identifier:N/A
A multicenter, multi-national, randomized, double-blind, placebo-controlled, study to assess the efficacy and safety of ciclesonide metered-dose inhaler (MDI) at 80 μg BID or 40 μg BID for 12 weeks in patients aged 4 to <12 years with persistent asthma.
asthma
Phase 3
No
Ciclesonide, Placebo
All
528
Interventional
4 Years - 11 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo MDI double-blind | Drug: Placebo Placebo MDI over twelve weeks |
Experimental: Ciclesonide MDI 40 µg BID double-blind | Drug: Ciclesonide Ciclesonide MDI 40 µg BID over twelve weeks |
Experimental: Ciclesonide MDI 80 µg BID double-blind | Drug: Ciclesonide Ciclesonide MDI 80 µg BID over twelve weeks |