Conditions: Perennial Allergic Rhinitis PAR
Keywords: Perennial Allergic Rhinitis PAR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 89
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when 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 multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single \[predose\] time point during the first domiciled period, and 24-hour sampling during the second domiciled period).

Arms:
arm 1: ciclesonide nasal aerosol (74 mcg) arm 2: None

Interventions: intervention 1: ciclesonide nasal aerosol intervention 2: Placebo
Intervention descriptions: intervention 1: ciclesonide nasal aerosol (74 mcg) intervention 2: Placebo

Protocol document: