Conditions: Perennial Allergic Rhinitis PAR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 848
Healthy volunteers: no

Brief summary:
This is a 12-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 of age with a diagnosis of PAR.

Detailed description:
This is a 12-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 of age with a diagnosis of PAR. This study will consist of the following periods/visits: Screening , Single-blind Placebo Run-in period, Double-blind Treatment period , Follow-up. The total duration of subject participation will be approximately 5 months.

Arms:
arm 1: ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily arm 2: ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily 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 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 dose per nostril

Protocol document: