Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

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

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.

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
• A known hypersensitivity to any corticosteroid