Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis Ciclesonide Ciclesonide Nasal Aerosol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 847
Healthy volunteers: no

Brief summary:
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

Detailed description:
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

This study will consist of the following:

Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

Arms:
arm 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg arm 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg arm 3: None

Interventions: intervention 1: Ciclesonide nasal aerosol 37 mcg intervention 2: ciclesonide nasal aerosol 74 mcg intervention 3: Placebo
Intervention descriptions: intervention 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg intervention 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg intervention 3: Placebo - one actuation per nostril

Protocol document: