NCT00790023

Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis

A Randomized, Multicenter, Double Blind, Placebo Controlled, Parallel Group, Phase III Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 707 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	80 mcg Ciclesonide	80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
DRUG	160 mcg Ciclesonide	160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
DRUG	Placebo	Placebo HFA Inhaler once daily (one actuation per nostril)

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-11-13
• Last updated: 2016-04-08
• Results posted: 2012-06-08

Locations

4 sites across 1 country: United States