NCT01458275

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 847 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

Detailed description

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR. This study will consist of the following: Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Ciclesonide nasal aerosol 37 mcg	ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
DRUG	ciclesonide nasal aerosol 74 mcg	ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
DRUG	Placebo	Placebo - one actuation per nostril

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-10-24
• Last updated: 2014-05-15
• Results posted: 2014-05-15

Locations

66 sites across 1 country: United States