Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
Study identifier:BY9010/M1-207
ClinicalTrials.gov identifier:NCT00163449
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Ciclesonide, Placebo
Sex
All
Actual Enrollment
1000
Study type
Interventional
Age
2 Years - 6 Years
Date
Study Start Date: 01 Nov 2005
Primary Completion Date: 01 Nov 2006
Study Completion Date: 01 May 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Dec 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Ciclesonide 40 µg | Drug: Ciclesonide Efficacy and Safety of Ciclesonide |
| Active Comparator: 2 Ciclesonide 80 µg | Drug: Ciclesonide Efficacy and Safety of Ciclesonide |
| Active Comparator: 3 Ciclesonide 160 µg | Drug: Ciclesonide Efficacy and Safety of Ciclesonide |
| Placebo Comparator: 4 Placebo | Drug: Placebo Placebo |
Contacts
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
