NCT01067105

A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 824 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.

Detailed description

This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). 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.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	ciclesonide HFA 160 μg	ciclesonide HFA 160 μg once daily

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-02-11
• Last updated: 2012-06-13
• Results posted: 2012-06-11

Locations

44 sites across 1 country: United States