Conditions: Seasonal Allergic Rhinitis
Keywords: SAR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 707
Healthy volunteers: no

Brief summary:
To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.

Detailed description:
This is a randomized, double blind, placebo controlled, parallel group, multicenter study to demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms:
arm 1: 80 mcg Ciclesonide once daily arm 2: 160 mcg Ciclesonide once daily arm 3: Placebo once daily

Interventions: intervention 1: 80 mcg Ciclesonide intervention 2: 160 mcg Ciclesonide intervention 3: Placebo
Intervention descriptions: intervention 1: 80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril) intervention 2: 160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril) intervention 3: Placebo HFA Inhaler once daily (one actuation per nostril)

Protocol document: