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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hay Fever, Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Ciclesonide nasal spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ciclesonide nasal spray|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician assessment of nasal symptoms score at endpoint |  |  | 
| average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment |  |  | 
| safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hay Fever, Seasonal Allergic Rhinitis, Nasal spray, Ciclesonide, Allergic Rhinitis