Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
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The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age
Study Start Date :
Actual Primary Completion Date :
Actual 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:
Written informed consent
General good health other than seasonal allergic rhinitis
Positive standard skin prick test
Main Exclusion Criteria:
Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
Participation in any investigational drug trial within the 30 days preceding the Screening Visit
A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
Use of any prohibited concomitant medications
Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
Study participation by more than one patient from the same household