Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
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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 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
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
6 Years to 11 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
Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
Main Exclusion Criteria:
Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
Use of any prohibited concomitant medications as defined by the study protocol
Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit