Safety and effectiveness of ciclesonide nasal spray in children (6 to 11 years) with perennial allergic rhinitis (BY9010/M1-403)
Study identifier:BY9010/M1-403
ClinicalTrials.gov identifier:NCT00163514
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age
Medical condition
Perennial Allergic Rhinitis
Phase
Phase 3
Healthy volunteers
No
Study drug
Ciclesonide
Sex
All
Actual Enrollment
636
Study type
Interventional
Age
6 Years - 11 Years
Date
Study Start Date: 01 May 2004
Primary Completion Date: 01 Jul 2005
Study Completion Date: 01 Jul 2005
Study design
Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
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Contacts
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
