Conditions: Seasonal Allergic Rhinitis
Keywords: Mountain Cedar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 671
Healthy volunteers: no

Brief summary:
This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.

Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. This study will consist of a Screening Period, followed by a Single-Blind Placebo Run-in period. The Double-blind Treatment period (14±2 days) will begin at randomization/Day 1 and consist of an interim visit 7±1 days after randomization, and an End of Study (EOS)/Early Termination (ET) visit. All subjects will have either a telephone contact, or in some cases an in-clinic visit, 7±2 days after their last study visit. 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: 160 μg once daily arm 2: 80 μg once daily arm 3: Placebo

Interventions: intervention 1: Ciclesonide HFA 160 μg intervention 2: Ciclesonide HFA 80 μg intervention 3: Placebo
Intervention descriptions: intervention 1: Ciclesonide HFA Nasal Aerosol 160 μg once daily intervention 2: Ciclesonide HFA Nasal Aerosol 80 μg once daily intervention 3: Placebo HFA Nasal Aerosol once daily

Protocol document: