Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
2 Years to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
General good health, other than perennial allergic rhinitis
History and diagnosis of perennial allergic rhinitis by skin prick test
History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit
Main Exclusion Criteria:
Participation in any investigational drug trial within the 30 days before the screening visit
Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit