Effect of high dose ciclesonide on asthma control - CONTRAST
Study identifier:CL-9709-301-RD
ClinicalTrials.gov identifier:NCT01455194
EudraCT identifier:2011-000683-99
CTIS identifier:N/A
Study Complete
Official Title
Control of moderate or severe asthma with 160, 320 and 640 mcg ciclesonide/day. A one-year randomised, double-blind, multicenter trial.
Medical condition
Bronchial Asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Ciclesonide
Sex
All
Actual Enrollment
520
Study type
Interventional
Age
12 Years - 70 Years
Date
Study Start Date: 01 Nov 2011
Primary Completion Date: 01 Aug 2014
Study Completion Date: 01 Aug 2014
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: CIC 160 Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg) | Drug: Ciclesonide During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg) |
| Active Comparator: CIC 320 Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg) | Drug: Ciclesonide During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg) |
| Active Comparator: CIC 640 Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg) | Drug: Ciclesonide During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg) |
Contacts
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
