Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:6 - 11
Updated:12/1/2016
Start Date:March 2006
End Date:October 2006

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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

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).


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
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North Dartmouth, Massachusetts 02747
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