Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)
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The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
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
Main Exclusion Criteria:
Participation in any investigational drug trial within the 30 days preceding the Screening Visit
A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
Use of any prohibited concomitant medications as defined by the study protocol