Finding studies
Finding studies
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Lead
Sumitomo Pharma America, Inc.
This study will investigate the efficacy and safety of once daily ciclesonide HFA Nasal Aerosol for 26 weeks. The primary objective is to evaluate the efficacy of ciclesonide HFA (80 mcg and 160 mcg) over 6 weeks, compared to placebo in subjects with PAR. Secondary objectives are to evaluate safety and tolerability and quality of life after treatment with ciclesonide HFA (80 mcg and 160 mcg), over 6 weeks and over 6 months. The study will consist of a Screening period (7 to 21 (±3) days) from Visit 1 to Visit 2, followed by a Single-blind Placebo Run-in period (7 to 10 days) from Visit 2 to Visit 3, followed by a 6-month (26 weeks) double-blind treatment period (Visit 3 through Visit 11). Subjects who complete this study will be allowed to participate in a 6-month open-label extension study (Study 060-635). 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.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
